Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
About The Position
The Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) will lead global regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This individual will be responsible for developing nonclinical and clinical regulatory strategies, supporting regulatory submissions, and serving as the regulatory liaison to internal nonclinical and clinical teams. This role requires strong experience in regulatory strategy for biologics or gene therapies and the ability to work cross-functionally with clinical development, clinical operations, nonclinical, quality and program leadership. This individual will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.
Requirements
- PhD, PharmD, MD or MS in life sciences, molecular biology, pharmacology, or related discipline.
- 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry (for Associate Director).
- Experience supporting INDs, CTAs, and early clinical development (for Associate Director).
- 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs (for Director).
- Proven experience leading regulatory submissions and interactions with agencies (for Director).
- Strong understanding of regulatory pathways for biologics and gene therapy products.
- Experience with nonclinical regulatory requirements for biologics.
- Excellent regulatory writing and communication skills.
- Ability to lead cross-functional teams and influence program strategy.
- Strong project management and organizational skills.
- Strategic thinking and problem solving
- Strong scientific and regulatory knowledge
- Cross-functional leadership and collaboration
- Clear communication and influence
- Ability to work in a fast-paced, early-stage biotech environment
Nice To Haves
- Direct experience with AAV, lentiviral, or other gene therapy platforms.
- Experience with rare disease development programs.
- Experience with global regulatory submissions including US and EU.
- Prior participation in regulatory agency meetings.
Responsibilities
- Develop and implement global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization.
- Provide regulatory guidance on nonclinical, clinical, and translational development plans.
- Identify regulatory risks and propose mitigation strategies to support program timelines.
- Contribute to overall product development strategy and lifecycle planning.
- Lead preparation and submission of global regulatory filings including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT and other expedited program submissions
- Ensure high-quality regulatory documentation aligned with agency expectations.
- Prepare regulatory briefing documents and support agency meetings.
- Serve as a subject matter expert for interactions with agencies including the FDA and EMA.
- Coordinate and author responses to health authority questions and information requests.
- Partner closely with internal teams including: Clinical Development, Clinical Operations, Nonclinical, Quality
- Serve as a regulatory representative on cross-functional program teams.
- Ensure alignment of development plans with global regulatory requirements.
- Monitor evolving regulations and guidance related to gene therapies and biologics.
- Interpret guidance documents and communicate regulatory expectations internally.
- Contribute to development of internal regulatory processes and best practices.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
