Hobson Prior currently have a 12-month contract opportunity for a Manager Regulatory Affairs CMC to join the Regulatory Affairs Team at a research-based biopharmaceutical company based in Cambridge.

Job 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.
• Uphold an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner.

Key Skills:

• 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.

Requirements:

• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.