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 Senior Manager (or Manager) to lead the preparation and review of INDs and CTAs and also support major marketing applications for their Sickle Cell Disease programs. You will prepare for agency meetings, submit responses to health authorities, 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!
- Contribute to global regulatory strategy and execution for a late stage rare disease program.
- 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.
- 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
- Assist team during regulatory agency inspections
Knowledge and Skills:
- BS in biochemistry, chemistry, biology or related pharmaceutical fields. Advanced degree (PhD, PharmD, MS) strongly preferred.
- Minimum 5-6 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.
- Understanding of the development of drugs and/or innovative biologics products.
- Experience in rare disease/orphan drugs or biologic therapeutics a plus.
- Must be knowledgeable in ICH, FDA and EMA guidelines. Global regulatory experience desired, but not required.
- 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.
- Must be adaptable, flexible, and comfortable with some level of ambiguity.
Please note that all candidates must be authorized to work in the US to be considered for this role. This company cannot support an H1B visa or visa transfer.