Job Description

Do you have experience with Regulatory Affairs specifically in an FDA regulated environment?

Have you worked in similar industries such as Cell Therapy, Gene Therapy, Biotech or Life Sciences? 

If you can answer Yes, and meet the minimum qualifications below, we want to talk to you today!

Functions and Responsibilities

  • Coordinate projects and activities across regulatory support functions in Europe and Japan in order to formalize and harmonize regulatory processes, procedures, and infrastructure across the network.

  • Responsible to maintain up to date knowledge of regulatory requirements for cell therapy products in both clinical and commercial phases and communicate changes in requirements through the organization.

  • Plan, coordinate, author, and/or review any submissions to FDA to ensure company requirements and relevant FDA requirements are met.

  • Liaise with Project Managers and participate on global client project teams to properly plan for and/or support client submissions to regulatory agencies, including but not limited to strategies for technology transfer, process/method validation, and stability.

  • Participate in due diligence activities for potential licensing opportunities and/or acquisitions.

  • Manage GMP licensing for North America sites and supports global sites in obtaining appropriate licenses to market product in the US.

  • Critically review complex reports and change control documentation for regulatory and risk mitigation strategies.

  • Ensure compliance to Pharmacopeia through monitoring of changes and careful implementation at sites.

  • Develop relationships with Health Authorities through external engagement via professional organizations, conferences, and committees.

  • Coordinate across Global Quality and across Sites to support inspection coordination in order to obtain the appropriate GMP certifications for each site.

  • Work with the Global Head of Quality and Regulatory to plan for the long-term strategy and development of the Regulatory Affairs Department, including the development of client service offerings.

  • Provide regulatory training to site level associates as a Subject Matter Expert.

  • Partner with the Global Quality Systems organization in order to maintain the accuracy of the Global Quality Manual and Standards.

  • Provide review of Global Quality Manual and Standards, as well as global and/or regional SOPs as required in order to verify compliance to regulatory expectations and standards.

Qualifications

  • BA/BS in the Life Sciences is required. MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred.

  • Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required

  • Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required. Knowledge of European and Japanese Health Authority requirements is strongly preferred

  • CMC Regulatory experience in cell therapies is required

  • Regulatory Affairs Certification preferred

  • Ability to work independently with minimal supervision is required

  • Proven interpersonal skills with face to face and remote teams

More Details
Employment Type: Full Time
Location: Allendale , New Jersey , United States
Experience Required: Director/ Vice-President
Date Published: 21 Sep 2022
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