Constant change is a hallmark of the life sciences industry. 2023 alone saw significant regulatory changes, such as the May lapse of the Federal Public Health Emergency (PHE) for the Covid-19 pandemic. This ended regulatory changes that benefited providers during the pandemic. From increased scrutiny of data integrity to a changing political landscape, Regulatory teams keep companies up to date with change. By managing Regulatory enforcement actions and maintaining compliance with changing local requirements, they help take products through to market. Let EPM Scientific find and deliver Regulatory talent to provide advice around biological products, drugs, human cell and tissue products, medical devices, and more.

How we can help

Your life sciences company can take advantage of over 10 years of experience in sourcing sought-after Regulatory talent. We invest in the ongoing growth, development of our talent specialists, in best-in-class technologies, and our extensive professional network of candidates to assure our clients of consistent quality service and find teams and individuals for Regulatory roles.

Regulatory talent solutions

Turn to EPM Scientific for your Regulatory talent needs, whether your company needs contract, permanent, or multi-hire solutions. Thanks to our global talent hubs, we will find proven and promising professionals and place them with speed and efficiency. We find and deliver interim managers and contractors for long-term and time-sensitive functions via our vast network of candidates, and we offer additional benefits through bespoke retained and contingent services.

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Benefits of working with us

Experience

We have over a decade’s worth of experience as a leading talent partner in Life Sciences & Pharma.

Network

A vast, global network of the best, in-demand professionals, working with the world’s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

Knowledge

Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

Looking to hire?

Regulatory Jobs

EPM Scientific can find your next Regulatory career opportunity in life sciences. We hire for roles including Director of Regulatory Affairs, Head of Quality Assurance and Regulatory Affairs, Senior Director Regulatory CMC, and Senior Clinical Regulatory Manager.

Senior/Executive Director Regulatory Affairs

Title: Senior/Executive Director Regulatory Affairs Summary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development. The S/E Director of Regulatory Affairs will be responsible for: Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teams Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy Prepare and lead teams in regulatory meetings and interactions with notified bodies Lead the authoring and review of regulatory documents in a timely manner Lead department initiatives and assist in training and oversight of the RA team Qualifications: 10+ years in Regulatory in biopharma industry or equivalent Must have experience in Oncology biologics Extensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products (IDE/IND/CTA/BLA/NDA) Ability to develop and implement regulatory strategies in the Oncology field Experience working with regulatory agencies and effectively move products through the development process Highly collaborative working style with the ability to work in cross-functional teams

US$250000 - US$310000 per annum

San Francisco

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Regulatory Affairs Manager

Title: Regulatory Affairs Manager Summary: This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organisation's goals. The Regulatory Affairs Manager will be responsible for… Developing and implementing regulatory strategies to ensure timely approvals of new and existing products. Manage and maintain product registrations, licenses, and regulatory compliance globally. Serve as the primary contact with regulatory agencies, including the US FDA, Notified Bodies, and other international entities. Oversee the preparation of regulatory submissions, ensuring accuracy and compliance with all regulatory requirements. Qualifications 5+ years of experience in the IVD regulatory medical device space Experience with EU IVD regulations

Negotiable

Massachusetts

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Senior/Executive Director Regulatory Affairs

Title: Senior/Executive Director Regulatory Affairs Summary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development. The S/E Director of Regulatory Affairs will be responsible for: Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teams Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy Prepare and lead teams in regulatory meetings and interactions with notified bodies Lead the authoring and review of regulatory documents in a timely manner Lead department initiatives and assist in training and oversight of the RA team Qualifications: 10+ years in Regulatory Affairs in biopharma industry or equivalent Extensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products and IVDs (IDE/IND/CTA/BLA/NDA) Ability to develop and implement regulatory strategies in the Oncology field Experience working with regulatory agencies and effectively move products through the development process Highly collaborative working style with the ability to work in cross-functional

US$250000 - US$310000 per annum

San Francisco

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Regulatory News & Insights

biometrics

Life Sciences Salary Guides of 2023

Are you aiming to advance your career within the life sciences sector? Are you interested in discovering your competitors‘ offerings for professionals in your field across the APAC region? We are excited to present our new series of Salary Guides for the life sciences industry. These comprehensive reports will furnish you with invaluable insights into the present salary trends in Singapore, China, Australia, South Korea, and Japan.Compiled from the responses of almost 900 life sciences professionals in the APAC region, this is an opportunity you shouldn't overlook. Seize the chance to gain a competitive advantage in the life sciences field, enabling you to make well-informed choices about your career trajectory, compensation, and hiring approaches.

management advice

The Life Sciences Skills Gap: How to Hire

The life sciences industry is rapidly growing, but it is experiencing skills gaps that need to be addressed to allow it to reach its full potential. According to a 2022 life sciences and pharma talent trends report, 33% of C-suite and human capital leaders in the life sciences and pharmaceuticals sector agree that talent scarcity is a major pain point. This problem is widespread, with the UK also suffering a skills shortage that threatens to stall the industry’s trajectory.Skills gaps in digital and computational skills, and industrial, economic, and clinical research are particularly large. However, if phenotypic, genomic, and patient data integration practices can be optimized across the industry, this will support both research and treatment advances in the future.This article shares effective hiring strategies that can help life sciences organizations address skill gaps within their teams and wider business.Understanding the skills gaps in the life sciences industryStatistics from the talent trends report highlight the key skills gaps in the life sciences industry and how they impact key research and development processes. Demand for life sciences products is forecast to grow more rapidly than the global GDP over the coming years, and 45% of the aforementioned talent leaders note that they are looking to hire primarily to avoid talent scarcity from hindering their organizations’ progress. Moreover, the report found that 67% of pharmaceutical and life sciences companies believe that reskilling their current employees is an efficient way to address and mitigate skills gaps. It currently takes 105 days on average to fill a non-executive life sciences position in the US, leading to financial losses of $500 per open role per day, so intentional talent strategies are crucial to setting life sciences businesses on the path to success.Supporting mobility between sectorsSupporting mobility between sectors plays a vital role in closing the skills gaps within the life sciences industry. Enabling professionals to transition across sectors, ranging from Regulatory and Legal Services to Pharmaceutical and Medical Device Engineering, allows life sciences companies to tap into a vast pool of talent. This is also an effective method of sharing intersectional knowledge and developing key skills.Selecting candidates with a diverse range of backgrounds for open roles may also bring more unique perspectives into your organization, thereby driving innovation and helping to meet growing demand. Focus on transferable skillsFocusing on transferable skills is a powerful approach to bridging the skills gap in the life sciences industry. Rather than solely emphasizing sector-specific experience, prioritizing transferable skills enables professionals to adapt and thrive in new roles within the field. The life sciences industry’s talent offers a myriad of transferable skills that can be used to power future growth and innovation. These include analytical skills, leadership and teamwork skills, problem solving, written and oral communication skills, management skills, and scientific peer communication. Additional soft skills to focus on in your talent acquisition strategy include critical thinking, problem solving, and attention to detail.Consider cultural fitSeek out candidates from other industries who align with your organization’s culture, values, and core mission. This alignment promotes employee engagement, retention, and overall job satisfaction, whilst creating a supportive working environment that benefits from a wide range of experiences and perspectives.These candidates should also possess the aforementioned transferable skills, which will help to ensure that they can perform optimally in their new roles without being hindered by common skills gaps.Offer more flexibilityWhile not a priority for all candidates, flexible working arrangements such as remote or hybrid work arrangements are valuable to skilled candidates and may help to give your organization an advantage in the ongoing competition for life sciences talent.Hire top talent with EPM ScientificEPM Scientific is a leading specialist life sciences talent partner, providing you with a wealth of expertise to help you locate the best talent for your life sciences roles globally. Submit a vacancy or request a call back from our team to find the right people to drive your organization forwards.

safety-pharmacovigilance

How to Ensure Employee Retention in Life Sciences

The Pharmaceutical market has expanded considerably in the past two decades, with Pharma revenues totalling $1.42tn in 2021. This has been accompanied by a growing demand for experienced, highly qualified Life Sciences professionals: with more drugs than ever now available, companies require a strong workforce to bring their products to market. The industry has had to deal with an ever-small talent pool as a result, which has been exacerbated by one of the highest employee churn rates, with the Life Sciences and Medical Devices industry alone seeing a 20.6% turnover rate. This is reflected in the results of our Life Sciences survey which revealed that more than 40% of Life Sciences professionals are currently looking for a new role.The COVID-19 pandemic led to a substantial increase in resignations across all industries, as many employees started to re-evaluate their priorities and seek roles that offered flexible remote-work policies. Consequently, companies have found it harder to get the people they need. 47.8 million workers in the U.S. decided to quit their jobs in 2021 – the highest volume of resignations since the Bureau of Labor Statistics began recording this data in 2001. This is equivalent to 3.98 million workers quitting their jobs each month, up from an average of roughly 3m leaving their jobs each month in 2019.Similar trends have been observed in Australia and the UK, where the rate of employed people between 16-64 choosing to switch jobs reached an all-time high of 3.2% between October-December 2021. The resignation rate continued to increase in 2022, with job-to-job resignations in the UK peaking at 442,000 in the second quarter of 2022. In Europe, one in three workers are considering quitting their jobs in the near term, with inadequate compensation and lack of career advancement being cited as the top factors.Why are Life Sciences professionals leaving their roles?The reasons that Life Sciences professionals have for wanting to leave their jobs vary across each industry sector. However, the promise of higher remuneration is invariably the main reason. This is according to findings from our Year in Review, which goes into greater depth about the factors that matter most to Life Sciences professionals when seeking to advance their careers.There are a host of other important factors, however, such as the desire for an improved work-life balance and employees wanting to acquire more new skills that will aid in their professional development. Changes in management can also cause people to want to move jobs, and Life Sciences professionals are increasingly looking for openings that provide flexible working hours and the ability to work from home.How to improve employee retentionThe good news is that there is a wide range of employee retention strategies that you can adopt in your workplace. Let’s take a look at some of the most effective employee retention techniques that you can use to ensure that your employees are satisfied at work and remain highly motivated in their positions, as opposed to looking elsewhere for their big career break.Offer competitive salaries and benefitsDissatisfaction around salary has had a negative impact on talent retention in the Life Sciences sector. As we’ve seen across the board, wanting higher compensation is the top reason for employees wanting to move to jobs; 70% of the R&D professionals that we surveyed within the Pharmacological industry were motivated by the promise of higher compensation at other companies.Paying your team a competitive rate is a simple but effective employee retention strategy that you can use to avoid your workforce shrinking. Our survey results show that the majority of respondents want a pay rise upwards of 10-15% of their current salary, which provides some indication of how much you may need to offer in order to remain competitive. Focus on career developmentYour employees will be far less likely to want to continue working for you long-term if there are few opportunities for advancement – or if their ability to develop their skills is limited. A study by Work Institute found that employees quit in 20% of cases due to career development issues.This highlights the importance of setting clear paths for career progression to give your team the motivation and provide them with long-term goals.Be flexibleOffering flexible working arrangements is a sure-fire way to keep your employees happy. Our Year in Review revealed that the option to work from home is very important to 60% of the industry as a whole. The majority of R&D respondents deemed flexibility as either important or very important, and workers in Pharmacovigilance ranked flexibility higher than salary when asked what is most important when considering a new job.Whilst a lack of flexible working options will not be a deal-breaker for many employees, you will find it far easier to retain your top talent if you grant them greater freedom to work according to their preferences.Build a supportive company cultureThere’s nothing quite like a warm, friendly culture when it comes to getting excellent work out of your employees. It’s also one of the best ways to increase their loyalty to the company.Seeking feedback from employees on a regular basis about how working processes might be improved helps ensure that workers feel that their concerns are being heard and addressed. Providing senior employees with the skills and training that they need to be good managers is also a worthwhile endeavour. Manufacturing professionals regard good leadership as almost as important as salary, according to our Year in Review survey.Promote work-life balanceMore than a third of respondents in our Life Sciences Year in Review report highlighted a poor work-life balance as one of the main reasons for wanting to seek employment in another role. Almost half of the Clinical Pharmacology professionals surveyed cited a need for an improved work-life balance as their main reason for seeking a new position.With higher numbers of professionals re-evaluating their priorities in life in the wake of the COVID pandemic, it’s no wonder that Life Sciences professionals are seeking out positions that allow them to spend more time with their families and friends. Giving your employees more personal time is therefore one of the most effective strategies for employee retention.Offer innovative, up-to-date technologiesFinally, ensure that you have the latest technology in your workplace. Investing in top-of-the-range software, for example, will make it easier for your employees to complete tasks and reduce the errors that are made, thereby increasing company productivity and boosting morale.Employee retention is critical to successThriving companies are characterized by a happy, satisfied workforce and high employee retention rates. Partner with EPM Scientific, a leading executive search firm for the Life Sciences industry, to find out more about how you can implement employee retention strategies that get results. Request a call back and one of our specialist consultants will be in touch.

Management & Culture

How to Determine if a New Hire Will Fit into Your Company's Culture

There’s no question that a company’s culture and ethos can help its employees feel more satisfied at work, increase employee retention and ultimately serve as a catalyst for its success. Company culture is seen as very important by professionals: survey data collected by Glassdoor shows that more than three quarters of professionals take the culture into account before applying for a job, and 56% say that they see the culture of a company as playing a more significant role than salary in determining overall job satisfaction. Given the role that it plays, cultural fit should be a key priority for employers.Why is cultural fit important?If somebody is a good cultural fit for a company, they are far more likely to be an engaged, motivated employee who derives satisfaction from their role. There is a greater chance that they will see the job as more than just a source of income and as such, they will be more likely to go above and beyond in the workplace and may even inspire others to follow in their footsteps.Hiring for cultural fit therefore makes good business sense. 10-25% of new employees decide to leave within six months of starting work, and one reason that professionals give for quitting is that they feel that they are a poor fit for the company culture. Choosing people for the job who are a natural fit for the company’s values and working practices is a great way to avoid these problems from arising.How to hire for cultural fit?Given the importance of company culture, businesses are increasingly hiring for cultural fit. This involves defining what your culture is all about and incorporating questions at interview stage that relate to your interviewees’ values, motivations and aspirations.Define your company’s cultureThe first step is to describe your company’s culture in writing. What are the values, beliefs and ethics that characterize your company’s operations and working environment? If you are struggling to capture the essence of your culture, it might be worth asking current employees about how they feel about the company and its working practices. It is recommended that you use such feedback when writing or updating a mission statement and articulating your company values. Include these on your website and on all your digital platforms, in addition to testimonials from your current employees.Demonstrate your values throughout the interview processAsking values-based interview questions is one of the best ways to identify candidates who share your values and will be a good fit in the workplace.You should also draw attention to the benefits that you offer your employees. 56% of CFOs in the Asia-Pacific (APAC) have said that they are considering expanding benefits, including flexible working arrangements (FWAs), in a bid to retain their top talent. If you offer flexible working roles, ensure that your staff relay this information at interview stage.Cover the right questionsIf you’re wondering how to determine if a candidate is a good fit, asking the following questions will help shed light on the personality of your interviewees and their alignment with your values:What motivates you? How do you handle conflict in the workplace?What work environment supports innovation and productivity levels? Give me an example of something that you have taught yourself in the last six monthsWhat experiences have shaped your outlook on life?What are you most proud of?Utilize personality testsPersonality tests provide valuable insights into how prospective employees approach problems. They can also shed light on their ability to work alongside others and offer further information about their interests and preferences.Some of the most common personality tests used by employers include the Myers-Briggs Type Indicator, the Caliper Profile and the 16 Personality Factor Questionnaire.Other key considerationsWhilst cultural fit is of great importance, it should be weighed alongside other factors. Hiring solely for cultural fit can perpetuate bias and lead to a lack of diversity within the workplace as a result. It’s also important to take into consideration an applicant’s qualifications, work experience, career aspirations and skill set when assessing their suitability for a role in your organization.Secure Life Sciences Talent with EPM ScientificAre you looking to solve your talent challenges? EPM Scientific offers bespoke talent solutions across Life Sciences A combination of our specialist account management service, ongoing support and reporting, and hiring advice allows us to find you exactly the people you need, when you need them. Register your vacancy or request a call back today.Our Talent Expertise

regulatory

Negotiating the salary you deserve 

When seeking a new job, it’s imperative to know the market, understand where you fit within it, and form a realistic salary expectation to stick to. A good talent partner will help you to know your worth within the industry and organization you’re interviewing for and will assist with communicating those expectations back to the hiring manager, but no one is a better advocate for you than you. Learning how to negotiate a salary when you receive a job offer is a vital skill for both now and in the future, and when done appropriately, will put you in a better position not just financially, but also in terms of how valued you feel in your role. We know that feeling appreciated and adequately compensated for our time, effort, and expertise has a direct impact on productivity, engagement, and general happiness within a company, so salary negotiations play an important part for both sides.It can be difficult to communicate those expectations as a professional hoping to onboard with a new company, and there is certainly a residual stigma around speaking about money and asking for more that is hard to overcome. At EPM Scientific, we have observed that professionals who negotiate their salary are presented with a much better job offer, so good communication skills and an understanding of your contribution can really pay off. As a general rule, always assume the offer is up for negotiation. And don’t forget to approach the process with positivity, as chances are the hiring manager isn’t crazy about negotiating, either. Here are our top tips on how to negotiate for the salary you deserve.Know the industry salary trendsTrying to negotiate for a higher salary without being familiar with industry trends will get you off to a bad start. Information is your biggest asset and conducting some research as well as speaking openly to a talent partner that knows your industry, the hiring company, and what you have to offer, will vastly improve your bargaining power. You can be a negotiating pro, but without being able to back up your requests with solid reasoning, it will be harder for the hiring company to take your expectations seriously. Pay particular attention to the most sought-after roles and skills within your industry and think about how your experience relates. Being able to recognize when your skills are transferable to a particularly in-demand area will add to your negotiation power. Start negotiating only when you have a firm offerThere is a process to be followed when it comes to receiving and accepting a job offer and understanding the etiquette will help your negotiation when the time comes. If you are interested in a position but it doesn’t meet your salary expectation, resist the temptation to bargain until the company has given you a formal offer. This is your signal that your skills, expertise, and personality are a strong match for the business and the role, and is a great asset to you when it’s time to tell them why you’re worth the higher salary. Once the ball is in your court, you can use the fact that they think you’re right for the job along with your understanding of the industry and the market to your advantage, making it harder for them to dismiss your requirements.It can also be worthwhile to take a reasonable amount of time to consider the offer rather than jump into negotiations. Tell the hiring manager that you’re serious about the offer and the position, but that you need some time to consider the whole picture. Be gracious and enthusiastic but take the time you need to prepare for negotiations and signal to them that there may be elements of the offer that don’t align with your requirements. Chances are they’ll have a counteroffer in mind for you.Build the business caseIn order for a company to seriously consider your request for an increased salary offer, it must make commercial sense for the business. Make a strong case, show that you understand the company's current financial situation, and know who has the power to negotiate. While likeability shouldn’t be underestimated in the hiring process and a large part of your job offer will be to do with character fit, it’s not enough for them to like you when it comes to financial compensation. They have to believe your worth in fiscal terms, so don’t expect your personal compatibility to get you the salary increase you want. Instead, explain precisely why your requirements are justified in a business sense; your glowing personality will just make them glad your business case checked out.Suggest an exact number for your salaryTime is of the essence, and hiring managers are particularly strapped for it while conducting interviews alongside their other duties. Therefore, they’ll likely appreciate a direct approach to your negotiation in terms of giving them the exact offer you’re looking for. It can be a powerful strategy in that it keeps the ball rolling and avoids pointless back and forth. Many studies suggest that candidates who use a specific number end up with a final offer much closer to the figure they were hoping for. Your potential employer will assume you have done your research on your market value and want to stay competitive in their offer. Don't suggest a range – you will always get offered the lowest if the manager knows there's room to haggle down.Reveal your current salary when negotiatingOutside the US, the hiring manager may ask what you are currently earning, which can be awkward if you feel you are currently being underpaid. It might be tempting to lie and state a higher salary more in line with what you’re seeking, but if you're unhappy with your current pay, it can be valuable to tell them why. Include all your benefits, bonuses and confidently explain the figure you're hoping for while making the case for why. If anything, they’ll have a more genuine understanding of what you know your worth to be, and that salary is important enough for you to walk away from a role that isn’t aligned with your requirements.Have a walk away pointKnow your limits and your expectations and keep them firmly in mind. Have a pre-considered ‘walk away’ point - the figure you’re absolutely unwilling to drop below. Base this on your financial need and the market value of the role, but keep in mind the role itself. Why are you interviewing for the position in the first place? Is your passion for the work worth lowering your salary expectations? Get help negotiating your salarySpeaking with a specialist talent partner will help you understand your worth in the context of current industry trends and the wider job market, too. At EPM Scientific, we can evaluate your profile against the wider talent pool, as well as align your expectations with that of our current database of hiring companies. We'll help you pitch your value at the right price during the salary negotiation process, giving you the best chance to make your next position a rewarding and fulfilling one. Get in touch for tailored advice.