Regulatory Affairs Manager

2 days ago


New Works, United Kingdom CK GROUP Full time

CK Group are recruiting for a Regulatory Affairs Manager to join a company in the Pharmaceutical industry working remotely with occasional meetings at their site based in Cambridge initially on a contract basis for 12 months.
**Daily Rate**:
£464.67 (Ltd/Umb) £370 (PAYE)
**Essential Requirements**:

- Degree or similar in a science or technical field such as pharmacy, biology, chemistry or biological science
- Knowledge of manufacturing, project, technical and regulatory management
- Knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- It is essential that applicants hold entitlement to work in the UK

**Regulatory Affairs Manager Role**:

- Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products
- Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders
- Documenting maintenance and communication of Health Authority approval status
- Project management expertise with the ability to adapt to changing situations to ensure on time delivery
- Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team

**Company**:
Our client is a global research-based bio pharmaceutical company with a major UK presence who are committed to making a meaningful impact on people’s lives with life-changing medicines. This is a worldwide brand name which will not only look fantastic on yourCV for years to come but also offer inspiring and rewarding work.
**Location**:
This Regulatory Affairs Manager will be remote based with occasional meetings at our clients site in Cambridge.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53947 in all correspondence.



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