Life Sciences Pharmaceuticals
An excellent opportunity has arisen for an experienced Regulatory Manager to join a global pharmaceutical Organisation at their site based in Brentford.
As a Regulatory Manager, responsibilities include:
- Ensuring that medicinal, medical device and cosmetic products can be legally sold and supported in compliance with regulations.
- Providing advice, recommendations and support for product claims, copy and labelling.
- Ensuring that all personnel are given adequate training and guidance in all aspects of regulatory affairs work, and to ensure that all regulatory systems and databases are up to date and effectively managed.
- Ensuring quality of both own and submission teamwork and compliance with regulatory guidelines and process within the required timelines.
- Maintenance activities associated with a defined portfolio, including product renewals, and routine PV activity.
- Setting and resetting priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.
- Creating and maintaining good working relationships within the Business and across Global Regulatory (GRA) functions, as well as other support functions, including factories and GMS teams, Quality, R&D, and with influential external bodies (Trade Associations and professional bodies).
- Leadership of preparation and review of day to day submissions with full accountability for delivery.
- Contributing to the assessment of innovation projects and exploratory product development briefs.
- Working with Category Regulatory Representatives, help develop the regulatory strategy or components of filing strategies designed to minimise time for development and regulatory approval and optimise competitive positioning and global opportunities.
- Liaising with Regulatory Agencies to resolve issues in relation to their accountabilities and lead regulatory interactions.
- Identifying challenges, developing and implements written procedures (e.g. local SOPs, work instructions), and proactively highlights opportunities for process improvement.
- Responsible for highlighting own training needs and working with his/ her manager to develop a training plan and achieve training goals.
This is an exciting opportunity and we look forward to receiving your application. For further information please feel free to contact Helen at CY Partners on 07851246847 / 0191 477 4733 or you can send your CV to [email protected]