Senior Regulatory Affairs Manager

1 day ago

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

Join Tarsh & Partners Marketing Recruitment in our search for a highly skilled Senior Regulatory Affairs Manager to lead our consumer healthcare team in the UK and Ireland.

About the Role

We are seeking an experienced Senior Regulatory Affairs specialist to manage and support a portfolio of consumer healthcare brands. The successful candidate will be responsible for developing regulatory strategies, preparing regulatory applications, and supporting maintenance activities.

Key Responsibilities
  • 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 authorisation
  • Support the monitoring of local regulatory intelligence for consumer healthcare team
  • Provide expert knowledge of the local regulatory authority (MHRA, HPRA etc.)
  • Strong collaboration with the 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
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 regulatory environment, interaction with the Regulatory Authorities, commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations
  • Experience and knowledge of local UK regulatory affairs requirements for consumer healthcare products
  • Pharmaceutical or scientific university degree would be an advantage

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