Associate Director of Regulatory Affairs
A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval compliance for a diverse portfolio of pharmaceutical products. This is a unique opportunity to join a purpose-driven organization focused on delivering better health outcomes through innovation, collaboration, and regulatory excellence.
The Associate Director main responsibilities will be…
- Develop and implement regulatory strategies for assigned BRANDED/PRESCRIPTION pharmaceutical products, including NDA, ANDA, BLA, OTC, and device categories.
- Serve as a regulatory lead on cross-functional product development and life-cycle management teams.
- Ensure timely and accurate preparation of regulatory submissions and responses to health authorities.
- Collaborate with global regulatory counterparts to ensure regional compliance and integration into product strategies.
- Support the development and maintenance of compliant product labeling in coordination with labeling leads.
- Act as a primary contact with regulatory agencies and support inspections and audits.
- Provide regulatory input for business development and due diligence activities.
- Contribute to annual planning and budgeting for regulatory activities.
- May manage or mentor junior regulatory staff.
The Associate Director must have the following qualifications:
- Bachelor's degree in a science or health-related field required; advanced degree preferred.
- Minimum of 6 years of regulatory affairs experience in the pharmaceutical industry, with strong knowledge of BRANDED/PRESCRIPTION product regulations.
- Experience across the product life-cycle, including development, labeling, advertising/promotion, and compliance.
- Familiarity with domestic and international regulatory frameworks.
- Ability to interpret and apply regulatory guidance to product strategy and documentation.
- Regulatory Affairs Certification (RAC) is a plus.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.