What are the responsibilities and job description for the Associate Director, Regulatory Affairs – Gene Therapy position at Confidential?
Job Title: Associate Director, Regulatory Affairs – Gene Therapy
Employment Type: Full-Time
Location: Malvern, PA (Onsite)
Overview
We are seeking an Associate Director of Regulatory Affairs to support gene therapy programs, driving regulatory strategy and submissions across clinical development. This role will partner cross-functionally to advance filings, support health authority interactions, and help bring innovative therapies to patients.
Key Responsibilities
Regulatory Strategy & Submissions
- Support development and execution of global regulatory strategies for gene therapy programs
- Lead preparation and review of INDs, IMPDs, BLAs, MAAs, and regulatory responses
- Collaborate with Clinical, Regulatory Ops, and other teams to ensure high-quality submissions
- Support interactions with global health authorities (FDA, EMA, PMDA, Health Canada)
- Monitor regulatory landscape and provide risk mitigation strategies
Clinical & Regulatory Oversight
- Provide regulatory input on clinical study design, endpoints, and development plans
- Author/review clinical regulatory documents (e.g., CSRs, briefing packages, summaries)
- Support clinical trial applications, amendments, and regulatory compliance requirements
- Contribute to accelerated pathways (e.g., Orphan Drug, Fast Track, RMAT, PRIME)
Cross-Functional Collaboration
- Partner with Clinical, QA, Regulatory Ops, and Medical Writing teams to align on deliverables
- Support regulatory processes, templates, and best practices
- Ensure alignment with evolving global regulatory requirements
Qualifications
- Bachelor’s or Master’s degree in Life Sciences (advanced degree preferred)
- 8 years of Regulatory Affairs experience in biotech/pharma
- Direct experience with IND, IMPD, BLA, and/or MAA submissions
- Experience in gene therapy, cell therapy, or biologics required
- Strong understanding of global regulatory requirements (FDA, EMA, etc.)
- Excellent communication and cross-functional collaboration skills
- Ability to manage multiple priorities and work in a fast-paced environment