Associate Director of Regulatory Affairs – FILLED

The Wellington Group has been retained to find a seasoned Associate Director of Regulatory Affairs with Pharmaceutical Promotional Materials and Submissions experience for one of North Carolina’s growing biotech companies with a focus on current and future medical technologies.

The Associate Director of Regulatory Affairs will provide regulatory support with the management of promotional materials and practices and preparation of submissions for new registrations.  The manager will be required to review, approve and monitor product advertising and promotional materials and product labeling.  The manager will also provide input on Medical Affairs and Corporate Communications practices to ensure compliance with applicable laws and regulations, industry best practices and the company’s procedures.  The manager will be responsible for the preparation and filing of regulatory submissions for new product applications (e.g. INDs, new BLAs, DINs, MAAs).

Responsibilities include:

  • Maintaining thorough knowledge of current rules and regulations governing advertisement and promotions, new product registration as well as recent FDA enforcement actions and communication trends
  • Developing, implementing and maintaining internal policies and procedures for appropriate review, approval and finalization of all ad/promo materials, promotional activities and product labeling
  • Developing and leading training for relevant internal staff on ad/promo policies, procedures and best practices
  • Preparation and management of submissions in support of new product registrations including new INDs, IND Amendments and Annual Reports, new BLAs, MAAs, DINs
  • Submission of advertising and promotional pieces to regulatory authorities
  • Interfacing with regulatory authorities regarding ad/promo submissions
  • Interface with CROs and other third parties for regulatory aspects of investigational trials support
  • Preparation and management of submissions in support of new product registrations

The qualified candidate will have:

  • Bachelor degree
  • 5+ years of  experience with FDA, CBER, CDER and/or USDA is preferred
  • 3+ years direct experience with new product registration and labeling submissions
  • Demonstrated knowledge of Regulatory Affairs within the pharmaceutical industry
  • Detail oriented and must be a strategic problem solver
  • Effective written and verbal communication skills
  • Ability to work cross functionally among other departments to uphold a team environment

 Industry: Pharmaceuticals, Labeling, Registration, Regulatory Affairs

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( 910-338-2795

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