My client is a clinical-stage biotechnology company focused on transforming the lives of patients with severe genetic and orphan diseases. They are seeking a Regulatory Affairs Manager to lead the preparation and review of INDs and CTAs and also support major marketing applications for one of their rare disease programs. You will prepare and submit responses to health authorities, prepare for agency meetings, and participate in negotiations with the FDA to resolve issues. This 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
- Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, and pediatric investigation plans
- Prepare submissions plans and manage timelines for regulatory submissions
- Participate in negotiations with regulatory agencies to resolve issues, and prepare and submit responses to questions
- 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, and internal style guidelines and requirements including SOPs
- 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.
- Minimum 2-4 years of regulatory experience in a biotech/pharma company, preferably in biologics
- 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.
- Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus
- Must be 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