Regulatory Affairs Specialist

4 days ago


High Wycombe, United Kingdom CK GROUP Full time

CK Group are recruiting for Regulatory Affairs Specialist to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 6 months. This role allows 2 days from home and 3 days in the office.
**Salary**:
Hourly £44.68 PAYE / £52.73 UMB/LTD
**Company**:
Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
**Location**:
High Wycombe. This site is the UKs head office of the worlds leading research based pharmaceutical company.
**Rewards**:
As a PAYE employee you will benefit from:

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

**Regulatory Affairs Specialist Role**:

- Support the team with regulatory activities for National and/or European procedures.
- Support the team with regulatory strategies (local and regional) in line with business plan.
- Support the team to complete identified regulatory activities.
- Prepare and compile regulatory submissions responses to Regulatory Agency (RA) questions.

**Your Background**:

- Life sciences or chemistry graduate to honours level or equivalent.
- Work with mínimal supervision to plan, conduct, and manage regulatory submissions and multiple projects.
- Work with mínimal supervision to determine and develop approaches to solutions with technical guidance.
- May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
- Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53449 in all correspondence.



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