North Carolina, USA
about 1 month ago
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
- 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
- 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 firstname.lastname@example.org