Principal Specialist, Regulatory Affairs
A growing biotechnology company is seeking a Principal Specialist, Regulatory Affairs (Health Authorities) to support global regulatory strategy and health authority submissions for investigational and marketed products. This role will partner closely with Clinical, Regulatory, and cross-functional teams to advance development programs and support critical regulatory filings.
Key Responsibilities
- Support global regulatory strategy and health authority interactions.
- Prepare and review INDs, CTAs, NDAs, BLAs, MAAs, and briefing documents.
- Draft responses to health authority questions and information requests.
- Review clinical data, reports, and submission content for accuracy and compliance.
- Support eCTD submissions and document management activities.
- Provide regulatory guidance to cross-functional teams.
- Monitor evolving global regulatory requirements and guidance.
- Support process improvements and special regulatory projects.
Qualifications
- Bachelor's degree with 10+ years or Master's degree with 8+ years of regulatory affairs experience.
- Experience supporting clinical regulatory submissions in eCTD format.
- Familiarity with health authority interactions and information request responses.
- Knowledge of global regulatory requirements and clinical development.
- Strong understanding of GCP and clinical documentation.
- Excellent organizational, communication, and project management skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Global submission experience 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 resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, 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.Â
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.Â
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.