CK Group are recruiting for a 12 month contract role as a Global Regulatory Scientist to join a biopharmaceutical company on a contract basis. The role is a hybrid role, inside IR35
The main purpose of the role will be to:
- Prepare and deliver regulatory operational plans for assigned projects/products within a specific region as agreed with the Regulatory Scientist Lead / Manager.
- Provide strategic and operational regulatory input and guidance in cross-functional teams, including managing quality regulatory submissions to agreed project targets.
- Work flexibly within and across regions (EU, MENA) to provide broad operational support to ensure the delivery of product team and business objectives.
Further responsibilities will include:
- Supporting the Global Regulatory Scientist Lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and regional/local country regulations.
- Coordinating preparation and delivery of both simple and complex submissions throughout the product?s life cycle from either a global and/or regional perspective.
- Liaising proactively with the functions and participating as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
To succeed in this role, you will come from a Life Science background with previous Regulatory Affairs experience.
- Strong communication skills to work with cross-functional delivery teams for complex submissions, providing regulatory advice
- Previous experience working on regulatory submissions, health authority briefing documents and response documents
- Experience working on regulatory standards and SOPs
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55498 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 55498
Website: CK Group
- Posted: 9th May 2023
- Expires: 6th June 2023