Manager Regulatory Affairs CMC
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Hobson Prior are currently seeking a Manager Regulatory Affairs CMC for an exciting position at a research-based biopharmaceutical company. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them. This position will be initially working remotely then will be based in Cambridge.
- Accountable to 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).
- You will co-ordinate the preparation of responses to CMC questions from regulatory authorities.
- Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals.
- Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner.
- Significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements is required.
- 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.
- Strong organisational skills and an ability to work on a number of projects with tight timelines.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.