CK Group are recruiting for a Regulatory Affairs Manager to join a global pharmaceutical company, based in Runcorn on a contract basis initially for 6 months.
Per Hour £53.96 PAYE / £70.33 Umbrella
Our clients aim is to be a global leader in generics and biopharmaceuticals, improving the lives of patients across the world.
Runcorn, this site specialises in difficult-to-make medicines which means the site is teeming with bright and ambitious professionals who are passionate about what they do. This site develops a range of sterile liquid products mainly for use in the treatment of respiratory conditions and also MS, for markets around the world.
Regulatory Affairs Manager Role:
- Provide Technical Leadership and Management of Regulatory Teams through coordination of resources across new product submission, site maintenance and regulatory compliance.
- Project Management to plan, resource and coordinate the delivery of projects to support the achievement of product launches and variations.
- Responsible for the strategy and execution of the site specific aspects of the preparation of CMC amendments and post market supplements.
- Support the preparation of regulatory filings, as needed and identify issues and factors that may implicate a regulatory strategy or activity.
- Educated to degree level or above in life sciences, chemistry or a related with field with extensive experience in Regulatory Affairs in the pharmaceutical industry.
- Extensive regulatory knowledge in pharma environments in the US, EU and IMT markets.
- Knowledge of cGMP regulatory requirements of pharma products/ development processes in drug product steriles.
- Excellent communication and Project Management skills.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55207 in all correspondence.
This role is subject to a satisfactory basic Disclosure and Barring Service (DBS) check. It is also 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
- Reference: 55207
Website: CK Group
- Posted: 6th March 2023
- Expires: 3rd April 2023