This growing biotech company is focused on transforming the lives of patients with severe genetic and orphan diseases. They are seeking a Regulatory Affairs Senior Manager (or Manager) to support major marketing applications in the US and Europe and also manage submissions of INDs, CTAs, Orphan Drug Applications, and Pediatric Investigation Plans. This company offers a fun, collaborative culture, a generous PTO package, and excellent benefits. Now is an exciting time to join this fast-paced, energetic, and rapidly growing company!
- Collaborate with regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications in the US and Europe; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
- Participate in negotiations with regulatory agencies to resolve issues, and prepare and submit responses to questions.
- Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, pediatric investigation plans.
- Prepare submissions plans and manage timelines for regulatory submissions.
- Act as primary regulatory liaison with Clinical team and external CROs to manage the initiation and conduct of clinical trials.
- Review technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, including cell and gene therapy guidelines, and internal style guidelines and requirements including SOPs.
- Manage regulatory documentation and submission logs.
- Participate in regulatory intelligence activities; monitor regulatory guidelines and trends.
Knowledge and Skills:
- BS in biochemistry, chemistry, biology or related pharmaceutical fields. Advanced degree (PhD, PharmD, MS) strongly preferred.
- Five or more years of regulatory affairs experience in biotech or pharmaceuticals.
- Excellent project management and writing skills, as well as a good understanding of the underlying science.
- Experience with preparation of initial INDs, CTAs, DSURs and meeting briefing documents. Experience with BLA, NDA, or MAA a plus.
- Experience in orphan drugs preferred but not required.
- Understanding of the development of advanced therapy/innovative biologics products a plus
- Knowledgeable in ICH, FDA and EMA guidelines
- Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions