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Regulatory Affairs Director

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Tarsh & Partners Marketing Recruitment Full time

Job Summary:

We are seeking an experienced Senior Manager Regulatory Affairs Specialist to join our team at Tarsh & Partners Marketing Recruitment. As a key member of our client's consumer healthcare team, you will be responsible for managing and supporting a portfolio of consumer healthcare brands.

Key Responsibilities:

  • Regulatory Strategy Development: Develop and implement regulatory strategies to ensure compliance with local, regional, and national regulations.
  • Marketing Authorisation Management: Maintain and seek new marketing authorisations through the National and European Procedures.
  • Regulatory Intelligence: Monitor local regulatory intelligence for consumer healthcare team and provide expert knowledge of the local regulatory authority.
  • Collaboration and Communication: Strong collaboration with local Commercial and R&D teams to ensure efficient compliance to external, local, regional legislation and internal compliance obligations and requirements.
  • Regulatory Advice: Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
  • Regulatory Best Practice: Ensure regulatory best practice at all times and monitor changes in the regulatory environment.

Candidate Requirements:

  • Background in Consumer Healthcare: A background in consumer healthcare in a local (UK) role.
  • Regulatory Experience: Experience in planning, conducting and managing regulatory submissions and multiple projects.
  • Project Management Skills: Proven project management skills.
  • Regulatory Knowledge: Robust understanding of regulatory environment, interaction with the Regulatory Authorities, commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.
  • UK Regulatory Affairs: Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products.
  • Education: Pharmaceutical or scientific university degree would be an advantage.