Job DetailsJob Location Main Corporate Office - Malvern, PA Description We are excited to welcome a dedicated and detail-oriented AD/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 AD/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.
QualificationsQualifications
- 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.
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.