Regulatory Affairs Manager (CMC) in Uxbridge
Jenni at CK Group is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Uxbridge on a 6 month contract basis.
The Company: Our client is one of the world's leading independent biotechnology companies, with global revenues in excess of $18 billion and over 18,000 employees. For more than 35 years, they have pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. They have not only discovered and developed innovative human therapeutics, but have invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
The Location: This position is based at their Uxbridge site, which opened in 2007. Uxbridge is located in the heart of the biopharma community west of London. It is ideally situated for easy access to all that central London has to offer. Uxbridge also boasts a significant and growing business population and is conveniently located just 15 minutes from Heathrow Airport.
The Role: The Regulatory professional will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.
Responsibilities will include to:
Ensure CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies.
Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries.
- Manage Strategy and Execution for all regulatory submissions.- Authoring and coordinating responses to questions across assigned products and countries.
- Point of Contact with local country regulatory staff.
- Project management of submissions and monitoring status of applications.
- Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders.
- Ensure regulatory product compliance for product.
- Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations.
- Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Provide guidance for regulatory assessments of change control requests.
- Set project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raise resource constraints.
- Document and communicate details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant senior management.
Your Background: To be considered for this role you should have the following knowledge and skills:
- Regulatory knowledge in regional legislation.
- Working with policies, procedures and SOPs.
- Experience with national legislation and regulations relating to medicinal products.
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development Scientific / Technical Excellence.
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
- Strong team player with a commitment to customer service.
- In-depth experience of pharmaceutical/biotechnology or medical device industry.
- Strong record of related experience within Regulatory Affairs.
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity.
- Strong computer skills, including word processing, database document repository and project management software attention to detail.
- Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect.
- Time and project management skills.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email email@example.com. Your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means you have not been shortlisted for the next stage of recruitment. Entitlement to work in the EEA is essential. Please quote reference 45490 in all correspondence.