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Regulatory Affairs Director

2 months ago

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

Highly Competitive Salary Package

Flexible Hybrid Working – Home Counties 2-3 Days/Week

Tarsh & Partners Marketing Recruitment is seeking an experienced Senior Regulatory Affairs specialist to manage and support a portfolio of consumer healthcare brands. This newly created role offers the opportunity for the successful candidate to shape and make it their own.

Key Responsibilities:

  • Develop and implement regulatory strategies, prepare regulatory applications, and support maintenance activities.
  • Maintain and seek new marketing authorisations through the National and European Procedures.
  • Develop and support regulatory strategies (local and regional).
  • Portfolio responsibility for full life cycle management, including local responsibilities to define and implement submission strategy for existing marketing authorisations such as safety changes, product information updates, re-classifications, renewals, etc.
  • Support the monitoring of local regulatory intelligence for consumer healthcare teams.
  • Provide expert knowledge of the local regulatory authority (MHRA, HPRA, etc.).
  • Collaborate closely with local Commercial and R&D teams.
  • Ensure efficient compliance to external, local, regional legislation, and internal compliance obligations and requirements.
  • 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 strong awareness/knowledge of current regulatory legislation.
  • Ensure regulatory best practice at all times.
  • Monitor changes in the regulatory environment and highlight any potential impact to 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 the Regulatory Authorities, commercial/strategic awareness, implementing regulatory strategy, managing and maintaining Marketing Authorisations.
  • Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products.
  • A pharmaceutical or scientific university degree would be an advantage.