Regulatory Affairs Consultant
PAYE 44.02 UMBRELLA 59.15
6 Month Contract
High Wycombe (remote work considered)
CPL Life Sciences are urgently seeking an experienced Regulatory Consultant on a 6 month contract to support the 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 clients 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
If this sounds of interest please apply within or email your CV to email@example.com
- Agency: Cpl Life Sciences
- Reference: JO-2204-491240
Website: Cpl Life Sciences
- Posted: 26th April 2022
- Expires: 24th May 2022