|Location: Wokingham||Salary: £45.00 - £52.00 per hour|
|Sector: Pharmaceuticals||Type: Contract|
|Contact: Matt Henocq||Job Published: 24 days ago|
Regulatory Affairs Manager
. 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 my 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 my clients products.
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
Services advertised by Gold Group are those of an Agency and/or an Employment Business.