Senior Manager/Associate Director, Regulatory Operations
Company: Ocugen, Inc.
Location: Malvern
Posted on: February 3, 2026
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Job Description:
Description Purpose The Senior Manager / Associate Director of
Regulatory Operations will lead the planning, preparation, and
execution of regulatory submissions to advance Ocugen’s biologics,
cell, and gene therapy programs. This role provides strategic and
operational leadership for global regulatory submission activities,
ensuring compliance with electronic submission standards, and
driving cross-functional alignment to meet critical regulatory
milestones. Responsibilities Regulatory Submission Leadership 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.
Regulatory Documentation & Compliance 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. Cross-Functional & Strategic Coordination
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. Team & Vendor Leadership
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.
Qualifications 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. Working Conditions This position operates in an
office setting, in person. Job may additionally require incumbent
to be available outside of these hours to handle priority business
needs. 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.
Keywords: Ocugen, Inc., Union , Senior Manager/Associate Director, Regulatory Operations, Science, Research & Development , Malvern, New Jersey
