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