Regulatory Affairs Manager
CK Group is recruiting for a Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months and has a hourly rate of £43.86 PAYE. This contract will be inside IR35.The 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. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Our client has been a biotechnology pioneer since 1980. They have grown to be one of the world's leading independent biotechnology companies, reaching millions of patients around the world. Currently they are developing a pipeline of medicines with breakaway potential.
Our client is situated about 3 km to the north of the historic and picturesque city of Cambridge. This location is easily accessible by car, train or by bus.
The purpose of this role is:
- To ensure that Amgen 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
- To ensure timely regulatory compliance with above approvals
The role may be responsible for:
- Advising the GRT on regional considerations in developing strategy
- Participating in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy (under general supervision)
- Providing regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plans)
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders • Participating as a member of: Global Regulatory Team (GRT), Evidence Generation Team (EGT), Clinical Study Team (CST), Regional Teams
- Acting as a contact with relevant regulatory agencies; documenting and communicating details and outcomes of regulatory agency interactions to GRT and relevant Management and Senior Management
To be considered for this role you should have the following key skills knowledge and experience:
- Knowledge of relevant legislation and regulations relating to medicinal products and of regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals
- Knowledge of drug development
- Working with policies, procedures and SOPs
- Cultural awareness and sensitivity to achieve results across both regional country and international borders
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47155 in all correspondence.