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 on a contract basis for 12 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: Hourly rate of £44 per hour PAYE dependant on experience.
Regulatory Affairs Manager Role:
- Ensure that the company acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
- Ensure timely regulatory compliance with above approvals.
- As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade).
- Understanding 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.
Apply: For more information or to apply for this Regulatory Affairs Manager position, please contact Julie on 01438 870011 or email email@example.com, quoting job ref 48390.
It is essential that applicants hold entitlement to work the UK.