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Regulatory Affairs Contractor - Buckingham, United Kingdom - Ark Talent Group

Ark Talent Group

Verified Company

Buckingham, United Kingdom

4 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Freelance

Description

Title:
Regulatory Affairs UK

Contract Length: 6 months with a possible extension

Location:
Hybrid - 2/3 days in High Wycombe

Our client is looking for a Regulatory Affairs contractor to support the Northern Cluster team for UK, Ireland and Malta products within a therapy area for Cosmetics, OTC and/or medical devices.

Key responsibilities will include:

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)
May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally
May represent Regulatory Affairs on crossfunctional product/project teams and provides regulatory advice (as appropriate)
Interactions with Regulatory Agency

Experience in commercial/strategic awareness, implementing regulatory strategy, managing and maintaining Marketing Authorisations are also essential requirements for this role.

You must also have experience in OTC.

Job Types:
Full-time, Temporary contract, Fixed term contract, Freelance

Contract length: 6 months

Salary:
£80.00-£84.00 per hour

Benefits: