Regulatory Affairs Manager - CMC

Regulatory Affairs Manager CMC

12 month contract

Regulatory Affairs CMC Manager

£57.29 per hour

40 hours per week

We have a 12 month contract opportunity for a Manager Regulatory Affairs CMC to join our client's Regulatory Affairs Team based in Cambridge.

Responsibilities;

• Support for MAAs, RTQs and post approval maintenance in EU regions
• Support for UK baseline variations as a result of Brexit and maintenance of UK licences
• Support for clinical programs including additional responsibilities for additional markets transferred from ROW team
• Rollout of variations in EU, Switzerland, Israel, UK and Balkans countries

• Support for new MAAs, RTQs and post approval maintenance in EU regions
• Support for UK baseline variations as a result of Brexit and maintenance of UK licences
• Support for clinical programs including additional responsibilities
• Rollout of variations in EU, Switzerland, Israel, UK and Balkans countries.

Duties include:

• Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in Europe including Switzerland, Balkans and Israel.
• Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for CTAs, marketing applications, variations and renewals
• Co-ordinate the preparation of responses to CMC questions from regulatory authorities
• Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner

Knowledge, Experience and Skills:

• Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
• Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
• Well versed and competent with regulatory documentation and submission management systems
• Excellent verbal, written and interpersonal communication skills are required
• Must have excellent organizational skills and an ability to work on a number of projects with tight timelines