Regulatory Specialist - Consumer Health
A large pharmaceutical company is in search of a Regulatory Specialist in Consumer Health to oversee specified products within a therapy area for Cosmetics, OTC and/or Medical Devices.
- 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.
- Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the department and functional policy
- Provide support with responses to ad hoc requests received from UK PV group or Global functions.
- Ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
- 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 to make key decisions on business-critical activities and project feasibility.
- Provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).
Skills and Requirements
- 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.