Title: Regulatory or Senior Regulatory Affairs Manager
Company: Pharmaceutical Company
Location: CA, NJ, PA, MA, NC
Type: Permanent Role
Notes: No Corp to Corp
This position will provide input on and support the development of Regulatory strategies at the Company. The position requires strong written communication skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information in order to prepare Regulatory documents. Individual must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.
- Must have extensive experience in clinical development and the Food and Drug Administration (FDA) regulatory process.
- In collaboration with the Regulatory Affairs Director, develop long- and short-term regulatory strategies.
- Responsible for day-to-day management of regulatory aspects of clinical development programs.
- Draft, review, edit, and coordinate FDA submissions.
- Identify and resolve regulatory issues by coordinating and obtaining input from Subject Matter Experts (SMEs) as needed.
- Assesses product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required.
- Provide regulatory support for manufacturing, packaging and labeling submissions.
- Provide guidance to external programs vendors and consultants
- Assist Director in negotiations with the FDA for assigned projects.
- Assess impact of new regulatory requirements or guidance documents and advise teams of the impact on the development programs.
- Bachelor's Degree with a minimum of 4 years regulatory affairs or a minimum of 2 years regulatory affairs with Master's Degree.
- Solid working knowledge of drug development process and US regulatory requirements required.
- Must have experience filing INDs.
- Experience in oncology drug development preferred; but not required.
- Regulatory Affairs Certification (RAC) preferred, but not required.