Regulatory Affairs Specialist

Regulatory Affairs Specialist

6 month contract

Out of Scope

Key responsibilities:

• Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
• Supports the Northern Europe Cluster team (as appropriate) for UK, Ireland & Malta across the Consumer Health portfolio range.
• Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
• Responsible for regulatory activities related to National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
• Define regulatory strategies (local and regional) in line with business plan.
• Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
• Prepares and compiles regulatory submissions (Marketing Authorisations Applications, Renewals Variations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines.
• Sign off packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions
• Ensure Marketing Authorisations are maintained and renewed, and sunset obligations are met
• 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 to track current product information.
• Supports the Northern Europe Regulatory team by assisting in any Pharmacovigilance related activities:
• Receive and monitor responses to Calls for Information (CFI) through liaison with UK and EAME colleagues.

Required Knwledge and Experience

• Life sciences or chemistry graduate to honours level or equivalent.
• Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience
• Brexit related regulatory knowledge and experience
• Must have hands on experience in management of day to day UK and EU regulatory procedures
• Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential
• 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 including processes
• 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.
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