Job Description

Jason Johal at CK Science is currently recruiting for a Regulatory Manager to join a global Biopharma company in East Anglia.

To find out more about this position, please watch Jason's short video here and read the job description below:



Regulatory Manager Job Description
As Regulatory Manager you will provide effective regulatory and strategic input during product development and product life cycle management to support manufacturing activities on site and to ensure regulatory compliance for final product release.

Reporting to both the Director of Quality Operations and to the Director of RA CMC Europe, as Regulatory Manager you will be responsible for 5 Quality Assurance and Regulatory Affairs professional staff and a budget up to $1MM. Your key responsibilities will include:

• Partnering with Global RA CMC to deliver the strategy and execution for the preparation of CMC components for investigational medicinal products, new marketing applications, MAA variations and responses to agency questions.

• Evaluation of post-approval CMC changes that affect EU MAA and International filings. Good working knowledge of EMA centralized variation system and variation application form. Scientific assessment of all relevant product related documents in compliance with EU regulatory requirements. Preparation of the EU quality components for CMC variations and maintenance of CMC sections in CTD format for EU MAA.

• Collecting and developing responses to questions from regulatory authorities in close cooperation with project team members in US and EU.

• Developing and maintaining a knowledge and understanding of current regulatory requirements for manufacture of API and testing, release and distribution of licensed medicinal products.

• Maintaining regulatory compliance system for therapeutic products to support final product release and distribution to market.

• Maintaining a high quality standards and a continuous improvement approach in responding to the evolving regulatory environment.

• Maintaining CMC regulatory documents and liaison with appropriate Regulatory Authorities. This includes Site Master Files and manufacturing licenses and other regulatory approvals are maintained and available for regulatory agency and Customer Inspections.


To be considered for this Regulatory Manager role you will have the following experience and skills:
• The ability to develop good working relationships with internal customers from QA/QC/Production/ Materials Management to improve regulatory compliance and awareness as well as collaboration with global regulatory personnel to ensure best practices and knowledge of global activities are communicated to site.
• Capable of working independently to achieve goals and objective and with the ability to prioritise and organise daily work to meet overall deadlines.
• The ability to influence others in a positive way and to identify and manage their own projects to completion.
• A good knowledge of Pharmaceutical manufacturing processes and cGMP is essential as is knowledge and experience of international regulatory affairs environment for product life cycle management.
• Practical experience of European regulatory procedures and the EU centralized procedure both pre and post approval are expected as is a good understanding of global change control management and regulatory compliance.
• The ability to work on a number of projects with tight timelines, good scientific writing skills and the ability to work independently with minimal guidance are also required.


How to apply:

For more information regarding this Regulatory Manager position, or to apply, please contact Jason Johal at CK Science on +XX (X)XXXX XXX XXX or email XXXXX. Please quote reference ST23896 in all correspondence.