Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
New
A
Atsena TherapeuticsGene therapy
Source API remote eligibility restrictions: United StatesFull-TimeDirector
Salary160,000 - 220,000 USD per year
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Job Details
- Experience
- Associate Director: 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry. Director: 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs.
Requirements
- PhD, PharmD, MD, or MS in life sciences, molecular biology, pharmacology, or a related discipline.
- Associate Director: 7–10 years of regulatory affairs experience in the biotech or pharmaceutical industry.
- Director: 10–15+ years of regulatory affairs experience, including leadership of regulatory strategy for development programs.
- Experience supporting INDs, CTAs, and early clinical development.
- Director candidates must have experience leading regulatory submissions and interactions with agencies.
- Demonstrated understanding of regulatory pathways for biologics and gene therapy products.
- Experience with nonclinical regulatory requirements for biologics.
- Strong regulatory writing skills.
- Ability to lead cross-functional teams and influence program strategy.
- Strong project management and organizational skills.
- Preferred: direct experience with AAV, lentiviral, or other gene therapy platforms.
- Preferred: experience with rare disease development programs and global submissions in the US and EU.
Responsibilities
- Develop and implement global regulatory strategies for gene therapy programs from preclinical development through commercialization.
- Provide regulatory guidance on nonclinical, clinical, and translational development plans.
- Identify regulatory risks and propose mitigation strategies to support program timelines.
- Lead preparation and submission of global regulatory filings, including INDs, IND amendments, CTAs, and IMPDs.
- Prepare regulatory briefing documents and support agency meetings.
- Coordinate and author responses to health authority questions and information requests.
- Partner with Clinical Development, Clinical Operations, Nonclinical, and Quality teams.
- Monitor evolving regulations and guidance for gene therapies and biologics, and communicate expectations internally.
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