Regulatory Affairs Manager - Berkshire

  • East of England/Anglia,East Midlands,West Midlands,London,South East Coast,South Central,South West
  • Highly competitive salary + benefits package
  • Ref: 7526

About the Job

Title: Regulatory Affairs Manager
Location: Berkshire
Therapy Area: Unlicensed Medicines
Salary: Highly competitive salary + exceptional benefits on offer
Evolve Consultant: Andy Boyd
Ref: 7526

We are currently looking to recruit a Regulatory Affairs Manager to join an exciting and growing Pharmaceutical organisation. The Regulatory Affairs Manager will conduct all associated regulatory activities for markets globally. The role will also contribute to the implementation, leading of projects and building of expertise within the Unlicensed Medicines space. This position reports directly to the Commercial Director. Based in the UK, there will be travel to Germany and the US offices

Interested? Please get in contact with us on 0113 457 0777 to speak to Andy Boyd.

Evolve is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

Role Responsibilities

  • Contribute to Cross-functional Teams and Build Regulatory Expertise and provide regular updates
  • Utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for unlicensed supply globally of products on behalf of clients
  • Attend relevant team and client meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary
  • Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities
  • Provide regulatory input to commercial strategic and operating planning process
  • Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.
  • Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests
  • Use knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers
  • Advise on matters of compliance, regulatory requirements, and regulatory policy
  • Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports
  • Utilise local knowledge of Regulatory authority’s expectations, ways of working etc to appropriately direct company strategy. Share updates with colleagues.
  • Work with authorities if company position differs from authority position to obtain a better outcome for the business/patients as appropriate
  • Populate and Maintain Regulatory Databases. Responsible for database entry and the document management of regulatory transactions undertaken at local level
  • Product Discontinuations: Liaise with internal and external client team/commercial/medical functions and advise on regulatory action required for discontinuation of a product in the country marketplace

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