Regulatory Affairs Director

2 days ago


High Wycombe, Buckinghamshire, United Kingdom Tarsh & Partners Marketing Recruitment Full time
Senior Manager Regulatory Affairs

Join our team at Tarsh & Partners Marketing Recruitment as we seek an experienced Senior Manager Regulatory Affairs to lead our consumer healthcare portfolio. This newly created role offers a unique opportunity to shape and drive regulatory strategies, ensuring compliance with local and regional legislation.

Key Responsibilities:

  • Develop and implement regulatory strategies, preparing and submitting regulatory applications and supporting maintenance activities.
  • Maintain and seek new marketing authorisations through national and European procedures.
  • Develop and support regulatory strategies, including local and regional responsibilities.
  • Portfolio management for full life cycle, including local responsibilities for defining and implementing submission strategies for existing marketing authorisations.
  • Support monitoring of local regulatory intelligence for the consumer healthcare team.
  • Provide expert knowledge of local regulatory authorities, such as the MHRA and HPRA.
  • Collaborate with local Commercial and R&D teams to ensure efficient compliance with external, local, and regional legislation and internal compliance obligations.
  • Represent local Regulatory Affairs in audits and inspections.
  • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
  • Maintain awareness of current regulatory legislation and ensure regulatory best practice at all times.
  • Monitor changes in the regulatory environment and highlight potential impacts on the company.

Candidate Requirements:

  • A background in consumer healthcare in a local (UK) role.
  • Experience in planning, conducting, and managing regulatory submissions and multiple projects.
  • Proven project management skills.
  • Robust understanding of the regulatory environment, interaction with regulatory authorities, commercial/strategic awareness, and implementation of regulatory strategies.
  • Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products.
  • A pharmaceutical or scientific university degree would be an advantage.


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