Regulatory Affairs Manager

2 weeks ago

Uxbridge, United Kingdom CK GROUP Full time

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge or Cambridge on a on a contract basis for 12 months.**Salary**:
Hourly: £45.56 PAYE or £60.35 Umbrella**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 geneticsto unravel the complexities of disease and understand the fundamentals of human biology. **Location**:
Uxbridge. This site is a Development Centre which was opened 2007. It is located in the heart of the biopharma community west of London. It is ideally situated for easy access to all that central London has to offer.**Rewards**:
As a PAYE employee you will be entitled to receive:

- Weekly/monthly payroll options
- Pension
- Timesheet system
- Bike schemes

**Regulatory Affairs Manager Role**:

- Support one or more products from a regional regulatory perspective.
- Work with cross-functional teams, including those in Development, Medical, Commercial, and Value and Access.
- Achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
- 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 and to ensure timely regulatory compliance with above approvals.

**Your Background**:

- Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
- Good knowledge of and experience in regional regulatory environment in relevant product area and development stage of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
- Experience with EU and national legislation and regulations relating to medicinal products
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.

**Apply**:

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