Regulatory Affairs Alliance Manager/Lead - 12 month role
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 therole 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 businessand 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 contactHendre 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.ing, coaching, and explaining.
Apply: For more information or to apply for this Manager Global Labelling position, please contact Ashleigh Williamson on 01438 842 978 or email awilliamson@ckgroup.co.uk, quoting job ref 52238.
It is essential that applicants hold entitlement to work in the UK.nce 52288.
CLINGENutcomes, retrospective and prospective data analyses, registry, epidemiology or health services research
- Expert insight and knowledge in Health economics and model development
- Skilled in translating complex economic concepts into simple language.
- Good understanding of current UK health care system and market access issues
- Demonstrated experience of project management
- Strong numeric skills
- Scientific/medical knowledge
- A commercial mindset
Apply: Entitlement to workin the UK is essential. For more information or to apply for this Health Economics Manager position, please contact Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. Please quote reference 52358 in all correspondence.