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Regulatory Affairs Manager – Charlotte, NC

Responsibilities

  • The Regulatory Affairs Manager will coordinate ANDA submissions to FDA, interact with regulatory agencies, serve as point of contact to local regulatory authorities, ensure progress on project teams, address state regulatory requirements, and coordinate with marketing for provincial submissions.
  • Perform change control evaluation; Identify need for new regulatory policies and implement new regulatory processes; and assist with development of new strategies and SOPs, as applicable.
  • Monitor and provide current status of guidance and regulations; and maintain awareness of competitive performance.
  • International and domestic travel.
  • Relocation provided, $95K-$120K.

Requirements

  • The Regulatory Affairs Manager will have a BS degree with a chemistry, pharma or biotech major.
  • Minimum of 5 years of experience in regulatory affairs in the pharmaceutical industry preferred.
  • Experience working with emerging facilities and complex dosage forms a plus.
  • Demonstrable experience working regulatory submissions and providing guidance and direction throughout the product life cycle.
  • Demonstrable knowledge of FDA/ICH regulation and guidance.
  • Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.

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