My client is actively hiring generics experts to build out their regulatory affairs team. Become part of a dynamic organization offering excellent salary, benefits, and room for professional growth!
The Regulatory Affairs Manager will oversee and guide Associates and/or Senior Associates in planning, authoring, compiling, and submitting regulatory submissions to the FDA. This person will play a key role in guaranteeing consistency, both internally and in relation to FDA guidelines, by planning, organizing, composing, and reviewing all submissions.
The ideal candidate will come from a strong generics background and possess substantial interpersonal skills to help navigate challenges faced by a rapidly growing company.
- Arrange and assemble new ANDAs, Amendments, Supplements, Annual Reports, and 505(b)(2) and 505(b)(1) filings.
- Rigorously review all documents intended to be submitted to the FDA.
- Lead, mentor, and motivate a team of 1 to 3 direct reports.
- Establish project plan due dates and monitor change management activities to ensure timely execution.
- Act as the regulatory representative to obtain documentation from team members and department representatives.
- 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.
- Effective communication and leadership skills, as well as the ability to analyze and determine the impact of regulatory complications.
A Bachelor's degree in a life science field is required, as well as at least 7 years in the pharmaceutical industry with a minimum 5 of those years in regulatory affairs (with an emphasis in generics) and at least 2 years of supervisory experience. An advanced degree is also preferred.
Please contact Melissa Riggi at 212-719-7526 or email your CV to email@example.com to be considered for this position!