Regulatory Affairs Specialist
Role: Regulatory Affairs Specialist
Duration: 6 Months
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, Malta, Sweden, Finland, Norway and Denmark products across the 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.
*Supports the Northern Cluster team with Calls for Information and assist in any Pharmacovigilance related activities within the Northern Cluster
*Receive and monitor responses to Calls for Information (CFI) through liaison with UK and EAME colleagues.
*Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.
*Provide support with responses to adhoc requests received from UK PV group or Global Reg Med Mailbox.
Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
For more information and immediate consideration please apply directly to this advert
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