Ocugen · 2 weeks ago
Senior Manager/Associate Director, Regulatory Operations
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
7+ years expOcugen is a biotechnology company focused on advancing biologics, cell, and gene therapy programs. The Senior Manager/Associate Director of Regulatory Operations will lead the planning and execution of regulatory submissions, ensuring compliance with global standards and driving cross-functional collaboration to meet regulatory milestones.
BiopharmaBiotechnologyHealth Care
Responsibilities
Lead and oversee the preparation, formatting, publishing, and submission of regulatory documents for INDs, IMPDs, BLAs, MAAs, and amendments
Ensure submissions are fully compliant with FDA, EMA, Health Canada, and ICH electronic submission standards (eCTD)
Provide oversight of regulatory publishing activities, including vendor management and internal coordination, to achieve on-time delivery
Establish and maintain submission trackers, dashboards, and metrics for organizational visibility and audit readiness
Provide high-level review of submission components (CMC, clinical, safety) for accuracy, consistency, and compliance
Drive best practices in document lifecycle management, including version control, archival, and audit preparedness
Serve as a subject matter expert, monitoring changes in regulatory requirements and proactively updating processes and systems
Partner with Regulatory Affairs, Clinical, CMC, Quality, and Medical Writing leadership to align submission strategies with development goals
Advise internal stakeholders on regulatory submission requirements, timelines, and risks
Lead collaboration with IT and external vendors to optimize submission platforms and tools, driving efficiency and compliance
Provide mentorship and guidance to junior Regulatory Operations staff
Manage vendor relationships to ensure quality and timeliness of outsourced publishing activities
Contribute to department planning, resource allocation, and process improvement initiatives
Qualification
Required
Bachelor's degree in life sciences or related field required; advanced degree preferred
7–10 years of experience in Regulatory Operations within the biotechnology or pharmaceutical industry, with increasing leadership responsibility
Proven expertise in global regulatory submission requirements, including FDA, EMA, Health Canada, and ICH guidelines
Demonstrated proficiency in eCTD publishing, electronic submission platforms, and regulatory information management systems (RIMS)
Experience managing teams and/or vendors to deliver complex submissions on accelerated timelines
Strong organizational skills with the ability to prioritize and lead multiple projects simultaneously
Exceptional communication and influencing skills; able to effectively partner with cross-functional leaders and external stakeholders
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 & Co-Founder
Arun Upadhyay
Chief Scientific Officer
Recent News
Company data provided by crunchbase