Senior Regulatory Cmc Executive

2 weeks ago


Brentford, United Kingdom CK GROUP Full time

CK Group are recruiting for a Senior Regulatory CMC Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis for 12 months.
**Salary**:
Per Day £435.72 PAYE / £569.62 UMB
**Company**:
Our client is a one of the largest global healthcare companies researching, developing and supplying innovative medicines, vaccines and healthcare products with their global headquarters in the UK. They invest around £1bn in research and development in theUK annually.
**Location**:
Brentford. This site is the UK headquarters for the company. It houses commercial and business functions as well as scientists and has around 800 staff at the facility.
**Rewards**:
As a PAYE employee you would be entitled to:

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

**Senior Regulatory CMC Executive Role**:

- Preparation of high quality, CMC detailed regulatory documents using varied information sources.
- Working to agreed deadlines and maintaining records to reflect project status
- Responsible for highlighting and sharing knowledge of regulatory documentation and procedures with others.
- Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
- May contribute to process improvement and/or regulatory intelligence projects.

**Your Background**:

- CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations.
- You will have strong understanding of CMC regulations, guidelines, procedures and policies.
- Post Approval CMC experience is required.
- Experience responding to manufacturing site change controls and providing regulatory advice and strategies.
- You will have the ability to stablish strong relationships and liaise effectively with business sites worldwide

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53867 in all correspondence.



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