Job DetailsJob Location Main Corporate Office - Malvern, PA
We are excited to welcome a dedicated and detail-oriented Manager of Regulatory Affairs to our dynamic team at Ocugen. In this key role, you will have the opportunity to contribute to the success of our global regulatory filings by collaborating with cross-functional teams to ensure excellence in clinical and CMC document preparation. Join us in advancing our product portfolio and driving innovation in regulatory affairs.
Job purpose
The Manager Regulatory Affairs is responsible for Clinical and CMC technical document review and writing, authoring and compiling the Clinical and CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory, Clinical, non-clinical and CMC technical writing objectives are met for Ocugen product portfolio.
Responsibilities
- Author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
- Author the CMC sections of the IND/IMPD, BLA/MAA, health authority questions, CMC based briefing documents to support the timely submissions of investigational and marketing applications for US FDA, EMEA and Health Canada.
- Ensure submissions are complete and accurate and comply with applicable regulatory requirements and expectations.
- Support the development and maintenance of regulatory templates, best practices and procedures.
cugen welcomes and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Qualifications
- 3-5 years of related experience with a related bachelor's degree or master's degree in life sciences required, advanced degree preferred (MS, PharmD)
- Prior experience in Biologics/Vaccines/Cell and Gene therapy preferred.
- Prior experience in scientific, regulatory and Medical Writing process and eCTD authoring
- Experience in filing IND, IMPD, BLA, MAA filings
- Excellent communication skills (Written, verbal, presentations)
- Ability to prioritize and handle multiple projects and priorities.