Head of Regulatory

Location: Essex  |  Essex  |  England
Sector: Life Sciences
Consultant: Steven Jeffers
Job Reference: SVJ356
Salary: £60000 - £70000
Job Status: Permanent / Full Time

Must have 8 years’ experience within Regulatory Operations in Pharma

Degree educated or higher in a science 

My client is a fast growing Pharma company looking to bring in an experienced Head of Regulatory, this individual will play a crucial role in the organisation; this position would suit someone looking to be hands on and act as a large cog in the organisation.

 

Job Purpose

  • To develop a regulatory strategy for company and drive this forward to implementation, in-keeping with the company’s commercial strategy
  • To lead, manage and grow the Regulatory team across companies key geographies
  • To be responsible for all communications to Regulatory Authorities, including regulatory submissions for all products
  • To be responsible for the timely delivery of appropriate quality submissions for ‘products under transition’ and ‘in-line’ products and represent the function at key meetings requiring Regulatory submission guidance and inputs on regulatory strategy
  • To evaluate and advise the Company on the adequacy of the content of regulatory submissions and identify deficiencies requiring further resolution

Key accountabilities

  • Develop Regulatory Strategy – To devise regulatory strategy and roadmap for considering which platforms and systems will be used to successfully reach pre-defined regulatory and commercial targets
  • Lead the Regulatory Department – To lead, manage and resource for the Regulatory department including in-line and projects’ products
  • Regulatory Submissions –  To contribute to, and ensure the quality of, the regulatory submissions including review for completeness, technical accuracy, and compliance
  • Stakeholder Relationships – To be responsible for developing strong relationships with internal and external stakeholders, in particular with the regulatory consultants currently used
  • Travelling will be required with the role within and outside the UK