Regulatory Affairs Manager - CMC

My client is a global biopharma company. They are seeking a Regulatory Affairs Manager (CMC) to join our Regulatory Affairs Team based in Cambridge on a 12 month contract.

Hybrid working

Key Responsibilities

• Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa)
• Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for 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.

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.