Associate Director, Regulatory Affairs
An innovative biotechnology company is seeking an Associate Director, Regulatory Affairs to serve as a key contributor within its Product Development Team. This individual will play a critical role in shaping regulatory strategy and leading U.S. regulatory submissions that support the advancement of a growing development pipeline.
Key Responsibilities
- Serve as the primary U.S. regulatory contact and manage interactions with FDA divisions.
- Contribute to regulatory strategy and integrated development planning, including use of expedited pathways.
- Lead preparation and management of FDA submissions (INDs, PSPs, meeting packages, Fast Track, BTD).
- Identify regulatory risks and collaborate with cross‑functional teams to develop mitigation plans.
- Oversee CRO‑led clinical trial submissions to ensure timely, high‑quality deliverables.
- Provide regulatory input on safety and clinical documents (DSURs, IBs, protocols, CSRs).
- Review external communications (e.g., ClinicalTrials.gov) for accuracy and compliance.
- Maintain complete, organized regulatory submission records.
- Develop and refine regulatory SOPs and processes.
Qualifications
- Bachelor's degree in Life Sciences or Pharmacy.
- 8-10 years of Regulatory Affairs experience, preferably in biotech.
- Strong track record with FDA submissions, including INDs and formal meeting packages.
- Experience with expedited programs (ODD, Fast Track, BTD) preferred; BLA/NDA experience a plus.
- Strong communicator with strategic thinking, attention to detail, and hands‑on execution ability.
- Effective team collaborator with strong project management skills.
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