Proclinical is currently recruiting for a Regulatory Affairs Consultant with a leading biopharmaceutical company located in Jersey City, NJ. As the RA Consultant, you will work independently and within group settings to act as a liaison between GRA and other functional areas, including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to health authorities.
- Actively contribute to the development and implementation of regulatory strategy for assigned projects.
- Prepare, coordinate, manage or maintain simple and complex regulatory submissions related to INDs, including initial applications, amendments, safety reports, DSURs/annual reports, meeting packages, and special pathway submissions in accordance with applicable regulations.
- Coordinate internal and external authoring, review, comment adjudication and finalization of submissions as applicable, including coordination with submission management/publishing and archival of final documentation.
- Provide review and comment during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content.
- Identify and resolve regulatory issues by coordinating and obtaining input from Subject Matter Experts (SMEs) as needed.
- Interface with and provide guidance to external regulatory groups/vendors (e.g., CRO, partner, consultants, etc.) in the preparation, review, compilation, finalization, approval and submission regulatory applications.
- Coordinate with Regulatory Project Management the development of reliable submission plans and timelines.
- Support GRA activities with other functional areas as required including representing GRA in cross-functional team meetings.
- Monitor company progress toward fulfillment of regulatory commitments.
- Contribute to local process improvements and initiatives to improve overall efficiency, quality and/or output within GRA, including the authoring and review of standard operating procedures (SOPs).
- Serve as a leader within GRA to help drive best practices.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.