Regulatory Affairs Associate Director

2 days ago


New Works, United Kingdom CK GROUP Full time

CK Group are recruiting for a Regulatory Affairs Associate Director to join a company in the Pharmaceutical industry working remotely/ offering hybrid working/ at their site based in Cambridge on a contract basis for 12 months.
**Daily Rate**:
£669 (Ltd/Umb) or £601 (PAYE)
Hours of work or shifts: 40 hours per week Monday to Friday
**Essential Requirements**:

- It is essential that applicants hold entitlement to work in the UK
- Must have current CMC understanding - global submissions not BAU
- Oncology experience
- CMC - Biologics or Synthetics experience
- Clinical background is a big advantage

**Regulatory Affairs Associate Director Role**:

- Manage the timely preparation and delivery of CMC contributions to the regulatory submissions.
- Project manage complex global CMC regulatory programs.
- Lead CMC submission management teams, ensure delivery of submission documentation.
- Highlight resource needs for product as appropriate for effective planning purposes.

**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 Associate Director role will Remote with occasional visit to office when required.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53943 in all correspondence.



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