RA Consultant

Highly Competitive Salary
  1. Permanent
  2. Consultant / Specialist, RA Intelligence
  3. United States
Jersey City, USA
Posting date: 13 Oct 2020
RA.NW.33502

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.

#LI-NW1

close