Regulatory Affairs Manager
CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Cambridge on a contract basis for 6 months.
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 Regulatory Affairs Manager role will be based at our clients site in Cambridge.
Salary: Up to £45.56 per hour PAYE.
Regulatory Affairs Manager Role:
- Acquire and maintain all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
- Work through the regionalleads to manage distributor markets Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within portfolio in compliance with global filing plans and local regulatory requirements.
- Advising the GRT on regional considerations in developing strategy.
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- Manage the product lifecycle for individual countriesper national agency requirements.
- Knowledge and skills of regulatory principles working with policies, procedures and SOP’s.
- Knowledge of relevant legislation and regulations relating to medicinal products awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
- Knowledge of drug development cultural awareness and sensitivity to achieve results across both regional country and International borders.
- Experience with EU and national legislation and regulations relating to medicinal products.
Apply: For more information or to apply for this Regulatory Affairs Manager position, please contact Dennis on 01438 870011 or email firstname.lastname@example.org, quoting job ref 51221.
It is essential that applicants hold entitlement to work in the UK.