Senior Regulatory Affairs Lead, Gene Therapy

Ocugen, Inc.; California; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Ocugen, Inc. seeks an Associate Director Regulatory Affairs – Gene Therapy to lead global regulatory strategy for our gene therapy portfolio.

This onsite role in Malvern, PA collaborates with Clinical, CMC, Quality, and Regulatory Operations to drive IND, BLA, and MAA submissions and prepare agency interactions. The ideal candidate has 8+ years in regulatory affairs within biotech/pharma, experience with regulatory submissions, and strong cross-functional communication to advance accelerated

Qualifications

• 8+ years in Regulatory Affairs within biotechnology/pharmaceuticals, with gene/cell therapy experience.

Responsibilities

• Design and execute global regulatory strategies for Ocugen’s gene therapy programs.

Education

Bachelor's or Master's degree in life sciences

Tools

IND Submissions

BLA Submissions

MAA Submissions

Job description

Ocugen, Inc. seeks an Associate Director Regulatory Affairs – Gene Therapy to lead global regulatory strategy for our gene therapy portfolio.

This onsite role in Malvern, PA collaborates with Clinical, CMC, Quality, and Regulatory Operations to drive IND, BLA, and MAA submissions and prepare agency interactions. The ideal candidate has 8+ years in regulatory affairs within biotech/pharma, experience with regulatory submissions, and strong cross-functional communication to advance accelerated