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Regulatory Affairs Alliance Manager/Lead - 12 month role

Berkshire   •  £64.10 per hour  •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Alliance Manager/Lead to join a global biopharmaceutical company at their site based in Slough on a contract basis for a period of 12 months, working remotely.

The Role:
The main purpose of the role will be to
- Provide global regulatory strategic and operational expertise to relevant key internal stakeholders and external commercial partner(s) to ensure qualitative and timely execution Regulatory Service Agreement in support of business and compliance needs.
- Lead, manage and provide oversight for regulatory deliverables and outputs, as well as support external regulatory commercial partners activities and services for the assigned regions and product(s) or business processes.
- Apply and develop specific product/business process management tools/systems (eg. PSMF updates, Compliance updates, RA deliverable oversight) to plan, monitor and report upon regulatory commercial partner services, activities and related budget.

Further responsibilities will include:
- Drive centrally the Regulatory Service Agreement (RSA) - Third Party Management Commercial Partner) BP process to execution
- Develop and optimise further the QMS process in alignment with Partnering Strategy (post-marketing and in development or co-development)
- Oversee RA Compliance of Commercial partners including deviation and CAPA ownership

Your Background:
To succeed in this role, you will come from a Life Science background with proven experience in a global regulatory affairs role in industry, including experience in Global Regulatory strategy and submissions management and interacting with multiple regions.
- Capable financial and budgetary management for RA partner services
- Excellent project leadership and project management skills; able to identify opportunities to improve project and process efficiencies

For more information or to apply for this Regulatory Affairs Alliance Manager/Lead position, please contact Hendre Moolman on 01438 842970 or email hmoolman@ckgroup.co.uk, quoting job ref 52233.
It is essential that applicants hold entitlement to work in the UK.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Hendre Moolman
  • Phone: 01438 743 047
  • Reference: 52233
  • Posted: 23rd November 2021
  • Expires: 21st December 2021

CK Group

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