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Regulatory Affairs Manager CMC - North Carolina

Regulatory Affairs Manager CMC - North Carolina

  • Location

    North Carolina, USA

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    23555_1621405447

  • Published:

    4 months ago

  • Expiry date:

    2021-06-18

  • Consultant:

    #

Job title: Regulatory Affairs Manager CMC - North Carolina

A global Pharmaceutical company with offices across the US are looking for a Regulatory Affairs Manager CMC. This role will be responsible for leading CMC submissions

Responsibilities:

  • Develop and maintain detailed timelines for global regulatory activities and submissions for assigned CMC projects
  • Track regulatory commitments and timelines for maintenance activities such as Post Marketing Commitments and Follow-up Measures
  • Ensure planning and coordination of activities to support regulatory submissions via the Regulatory Submission Team.
  • Work with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements

Requirements:

  • Degree in Biological Science, Allied Medical discipline or Pharmacy
  • 7+ years relevant Regulatory Affairs experience
  • Experience in biologicals is advantageous.
  • Extensive experience within Regulatory Affairs CMC

Salary and benefits:

A competitive salary, annual bonus and wider benefits package is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk