Title: Senior Associate of Regulatory Affairs
Summary:
A leading, global pharmaceutical client of ours is looking to hire a Senior Associate of Regulatory Affairs, based out of their New Jersey office. This rapidly growing client has drug products spanning generics, branded prescriptions, and injectables. This role will specifically focus within the client's generic portfolio which covers oncology, cardiology, respiratory, and neurology. The main function of the Senior Associate of Regulatory Affairs is to author, compile, review, and schedule regulatory submissions compliant with FDA and ICH requirements. This role will give you a great opportunity to contribute to the company's mission of producing high-quality and accessible medicines for all.
The Sr. Associate will be responsible for…
- Oversee and manage the compilation of regulatory submissions while ensuring compliance with FDA standards and internal requirements.
- Collaborate with cross-functional teams to coordinate and facilitate the procurement of required documentation, ensuring departmental timelines are met.
- Represent regulatory affairs in project team meetings, providing regulatory guidance and recommendations to support scheduling timelines and resolve technical issues.
- Independently author, compile, review, and submit high-quality, complex original ANDAs, NDAs, Amendments, Supplements, Annual Reports, and responses to FDA inquiries to ensure timely approvals.
- Review technical documents for accuracy and suitability for inclusion in new ANDAs, NDAs, 505(b)(2) applications, amendments, supplements, annual reports, and other FDA filings.
- Work closely with project team members and departmental representatives to gather necessary documentation, establish timelines, and ensure complete and accurate submissions.
- Review eCTD modules and verify proper hypertext linking for compliance and accuracy.
The Sr. Associate should have the following qualifications:
- Bachelor's degree in a life science discipline required.
- At least 5 years of experience in the pharmaceutical industry, including 3-4 years in regulatory affairs.
- Strong knowledge of FDA guidelines with a proven ability to apply regulatory requirements effectively.
- Commitment to the highest ethical standards, ensuring the delivery of high-quality, compliant submissions to the FDA.
