Associate Director, Regulatory Affairs – Gene Therapy
Confidential, Malvern, PA, United States
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
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