Regulatory Affairs Manager – CMC Europe
CK Group are recruiting for a CMC Regulatory Manager to join a biopharmaceutical company at their site based in Cambridge on a contract basis for 12 months.
- 43.80 PAYE
CMC Regulatory Manager Role:
- Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
- Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
- Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial and variations)
- Authoring and coordinating responses to questions across assigned products and countries.
- Point of Contact with local country regulatory staff
- Project management of submissions and monitoring status of applications
- In-depth experience of pharmaceutical/biotechnology or medical device industry
- Strong record of related experience within Regulatory Affairs (min 5 years)
- Regulatory knowledge in regional legislation
- Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Location: This CMC Regulatory Manager role will be based either remotely or at our clients site in Cambridge.
For more information, please contact Lucy on 01246 457739 or email email@example.com. Please quote reference 49371.