Director of Regulatory Affairs

Description

Job Purpose

The Director of Regulatory Affairs will lead regulatory strategy, submission planning, and execution for Ocugen’s biologics, cell, and gene therapy programs. This role is responsible for overseeing clinical and CMC regulatory activities, ensuring compliance with global regulatory requirements, and guiding cross-functional teams through regulatory processes. This leadership role will drive regulatory submission excellence, ensuring highest quality, delivered on time, process optimization, and innovation in regulatory filings across multiple health authorities including FDA, EMA, Health Canada, PMDA, LATAM, MENA and other global agencies. The director may serve as the key regulatory contact for FDA interactions. This is an onsite role.

Key Responsibilities

Regulatory Strategy & Submissions

• Responsible for all aspects of executing global regulatory strategy for products under development and approved products.
• Collaborate with stakeholder teams such as Clinical Development, Clinical Operations, Supply Chain, Project Management, Quality Assurance and other Ocugen business partners to develop Clinical, Pre-clinical, CMC and labeling sections of the Regulatory dossiers.
• Drives timely preparation, authoring, review, and submission of high-quality regulatory documents, to support development, registration and lifecycle maintenance submission for INDs, IMPDs, BLAs, MAAs, briefing documents and Responses to Agency questions.
• Lead packages for Health Authority interactions, including FDA, EMA, and Health Canada, ensuring alignment with regulatory expectations.
• Ensure compliance with evolving global regulatory requirements and proactively assess risks, providing mitigation strategies.
• Drive regulatory planning and timelines for investigational and marketing applications.
• Lead and manage Regulatory Operations team, publishing activities, management of Veeva RIM, Starting Point templates, Lorenz docuBridge platforms, expert knowledge of eCTD submission requirements and lifecycle management of eCTD submissions.
  
  
  

Clinical & Safety Regulatory Oversight

• Author, review, and manage clinical and safety documents, including Clinical Study Reports (CSRs), Risk Management Plans (RMPs), clinical summaries, and regulatory briefing books.
• Provide strategic regulatory input on study designs, endpoints, and clinical development plans.
• Support the regulatory aspects of clinical trial applications, amendments, and post-marketing requirements.
• Provide guidance and lead accelerated regulatory pathways such as Orphan Drug Designation, Fast Track, Breakthrough Designation, Regenerative Medicine Advanced Therapy (RMAT), PRIME and ATMP, Compassionate Use, Pediatric Investigation Plans.
• Ensure all regulatory commitment and requirements are fulfilled on time and accurately, including annual reports, DSUR and clinical trial registries.
• Plan and prepare for agency meetings with FDA, EMA, Health Canada & PMDA.
  
  
  

CMC Regulatory Oversight

• Lead the development and execution of CMC regulatory strategies for biologics, cell therapy, and gene therapy products.
• Oversee the authoring and review of CMC sections for regulatory submissions, including INDs, IMPDs, BLAs, and MAAs with applicable scientific standards, considering the evolving regulatory requirements.
• Serve as a key strategic partner with matrix teams such as Product development, R&D, Quality Assurance, Manufacturing, Supply Chain and Ocugen’ s business partners by providing strategic direction and guidance.
• Delivers CMC regulatory strategy to support major inspections such as PAI or Quality Incidents (Product Complaints, Recalls).
  
  
  

Collaboration & Compliance

• Serve as a key strategic partner with internal teams including Clinical, CMC, Quality, Medical Writing, and Regulatory Affairs to ensure alignment of regulatory objectives.
• Lead and oversee the development and maintenance of regulatory templates, best practices, and procedures.
• Stay current with global regulatory guidelines and proactively update internal teams on industry practices.
• Represent Ocugen in external regulatory discussions, advisory boards, and industry forums.
• May be involved in business-critical activities for Ocugen by providing Regulatory support / advice to in-licensing and divestment efforts.
  
  
  

Qualifications

• Bachelor’s or master’s degree in life sciences required; advanced degree preferred (MS, PhD, PharmD).
• 10 years of experience in Regulatory Affairs within the biotechnology or pharmaceutical industry, preferably in biologics, vaccines or gene therapy with proven track record of success.
• Proven hands-on experience with leading, preparation and successful IND, IMPD, BLA, and MAA filings.
• Expertise in clinical, CMC, and safety regulatory requirements, including regulatory writing.
• Must have global regulatory clinical trial experience, including EU CTR.
• Experience with late stage and pivotal registration studies preferred.
• Strong understanding of FDA, EMA, Health Canada, LATAM, MENA, PMDA requirements and ICH guidelines.
• Ability to lead cross-functional teams, manage multiple projects, and meet tight deadlines.
• Excellent written & verbal communication skills to accommodate different views and opinions to influence an aligned path forward.
• Highly motivated to perform hands on activities, decisive, results oriented, flexible, and ability to handle cross functional activities with minimum supervision.
• Ability to understand and communicate CMC and clinical information.
• Ability to anticipate and mitigate future strategic issues and uncertainties, resolve conflicts and develop a course of action.
• A leader with adaptability, acts with integrity and builds trust, and skills in gathering, analyzing and applying key information to solve complex problems while understanding long term impact of decisions and actions.
  
  
  

Working conditions

• Incumbent will primarily work Monday – Friday during normal business hours onsite at Malvern, PA.
  
  
  

Direct reports

• This position will have direct reports.
  
  
  

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.