Ocugen · 2 weeks ago
Associate Director Regulatory Affairs -Gene Therapy
Malvern, PA
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expOcugen is a biotechnology company focused on developing innovative therapies. The Associate Director of Regulatory Affairs - Gene Therapy will support the development and execution of regulatory strategies for the company's gene therapy portfolio, ensuring compliance with global regulatory requirements and driving regulatory submissions.
BiopharmaBiotechnologyHealth Care
Responsibilities
Contribute to the design and execution of global regulatory strategy for Ocugen’s gene therapy programs
Collaborate with Clinical Development, Clinical Operations, CMC, Quality Assurance, and Project Management to prepare regulatory sections for INDs, IMPDs, BLAs, MAAs, briefing documents, and responses to agency questions
Drive the preparation, authoring, and review of high-quality regulatory documents to support development, registration, and lifecycle management
Support health authority interactions (FDA, EMA, Health Canada, PMDA), ensuring alignment with regulatory expectations and preparation of meeting packages
Monitor evolving regulatory requirements, proactively assess risk, and provide recommendations for mitigation
Author, review, and manage clinical and safety-related documents such as CSRs, RMPs, clinical summaries, and regulatory briefing packages
Provide regulatory input on study designs, endpoints, and clinical development plans
Support regulatory applications and amendments for clinical trials, including EU CTR compliance
Assist with accelerated regulatory pathways (e.g., Orphan Drug, Fast Track, RMAT, PRIME, ATMP) to expedite development
Ensure fulfillment of regulatory commitments, including annual reports, DSURs, and clinical trial registry compliance
Support the development and execution of CMC regulatory strategies for gene therapy products
Contribute to authoring and reviewing CMC sections of submissions, ensuring compliance with scientific and regulatory standards
Partner with Product Development, Manufacturing, Supply Chain, and QA to align CMC documentation with program timelines and regulatory expectations
Partner with cross-functional teams (Clinical, CMC, QA, Regulatory Ops, Medical Writing) to align on regulatory deliverables and timelines
Support the development and maintenance of regulatory best practices, templates, and procedures
Keep internal teams updated on global regulatory requirements and emerging industry practices
Represent Ocugen in regulatory discussions and contribute to external advisory forums where appropriate
Qualification
Required
Bachelor's or Master's degree in life sciences required
8+ years of experience in Regulatory Affairs within biotechnology or pharmaceuticals, with direct experience in gene therapy, cell therapy, or biologics
Proven hands-on experience with IND, IMPD, BLA, and/or MAA submissions
Strong understanding of regulatory requirements in clinical and CMC domains, with ability to contribute to both
Familiarity with global regulatory agency requirements, including FDA, EMA, Health Canada, and PMDA
Experience with pivotal/late-stage programs a plus
Excellent organizational, written, and verbal communication skills with the ability to influence cross-functional partners
Ability to manage multiple priorities, anticipate regulatory risks, and provide practical solutions
Demonstrates adaptability, integrity, and the ability to work independently while fostering cross-functional collaboration
Preferred
advanced degree (MS, PhD, PharmD)
Company
Ocugen
Ocugen is a biotechnology company that develops novel gene and cell therapies to improve health and patient outcomes.
51-200 employees
H1B Sponsorship
Ocugen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$291.5MKey Investors
Janus Henderson InvestorsAvenue Capital Group
2025-08-08Post Ipo Equity· $20M
2024-11-07Post Ipo Debt· $30M
2024-07-31Post Ipo Equity· $35M
Leadership Team
Shankar Musunuri
Chairman, CEO & Co-Founder
Arun Upadhyay
Chief Scientific Officer
Recent News
Company data provided by crunchbase