Regulatory Specialist - Consumer Health

£50000 - £55000 per annum
  1. Permanent
  2. Consultant / Specialist
  3. United Kingdom
Maidenhead, England
Posting date: 17 Mar 2021
36399

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.

Job Responsibilities

  • 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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