My client is actively hiring ANDA experts to build out their regulatory affairs team. Become part of a dynamic organization offering excellent salary, benefits, and room for professional growth!
The Senior Associate of Regulatory Affairs will author, compile, review, and submit regulatory submissions to the FDA. This person will play a hand in communicating information about regulatory submissions throughout the organization and will provide guidance on regulatory strategy.
The ideal candidate will come from a strong generics background and possess strong interpersonal skills to help navigate challenges faced by a rapidly growing company.
- Independently author, compile, and review the accuracy of ANDAs, NDAs, Amendments, Supplements, and Annual Reports.
- Review and approve change control documentation through the scope of regulatory guidelines and applicable federal laws.
- Formulate strategies in support of submission goals.
- Act as representative of regulatory affairs team both externally and internally.
- In-depth knowledge and understanding of FDA guidelines with demonstrated success working in a generics pharmaceutical environment.
- Ability to effectively prioritize tasks in a fast-paced, small company environment.
- Expert knowledge of ANDA submissions.
A Bachelor's degree in a life science field is required, as well as 3-4 years of hands-on regulatory affairs experience in generics.
Please contact Melissa Riggi at 212-719-7526 or email your CV to firstname.lastname@example.org to be considered for this position!