Jason Johal at CK Science is currently recruiting for a Regulatory Manager to join a global Biopharma company in East Anglia and close to Cambridge
The role of this Regulatory Manager job is to 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. This is a dual reporting role to the Director of Quality Operations and to the Director of RA CMC Europe.
As a Regulatory Manager you will have responsibility for 5 Quality Assurance and Regulatory Affairs professional staff and a budget up to $1MM key responsibilities 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.
Qualifications and Skills:
This Regulatory Manager role will require 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.
The company require someone capable of working independently to achieve goals and objective and with the ability to prioritise and organise daily work to meet overall deadlines. They must be able to influence others in a positive way and to identify and manage their own projects to completion. They will need the following:
- 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 or to apply for this Regulatory Manager role please contact Jason Johal on 01438 723 500 or email firstname.lastname@example.org. Please quote reference ST23896 in all correspondence.