RA Consultant job in Jersey City, USA

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Job type: Permanent

Discipline: Consultant / Specialist, RA Intelligence

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities:

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 n.walker@proclinical.com.

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.

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