Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices.
? Supports the Northern Cluster team (as appropriate) for UK, Ireland and Malta products across the clients portfolio range.
? Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
? Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
? Supports the team with regulatory strategies (local and regional) in line with business plan.
? Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
? Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
? Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
? Ensure Marketing Authorisations are maintained and renewed.
? Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
? Ensures compliance within the department by ensuring
? Global, EAME and local databases are fully maintained.
? Processes, SOPs, working instructions and Job Aids are adhered to.
? Update relevant local and global databases (e.g Documentum, Aris, Connect etc.) to track current product information.
? Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
Good Regulatory Practice
? Maintain awareness/knowledge of current regulatory legislation.
? Ensures regulatory best practice at all times.
? Monitor changes in the regulatory environment and highlight any potential impact on McNeil Products Ltd / client products.
? May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
? May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
? Interactions with Regulatory Agency
? Provides regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
? If required, represent the client and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).
SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE
? Life sciences or chemistry graduate to honours level or equivalent.
? Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
? Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
? May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
? Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org
- Agency: Achieva Group Limited
- Reference: BH-33273
Website: Achieva Group Limited
- Posted: 6th May 2022
- Expires: 3rd June 2022