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Regulatory Team Lead

2 months ago

Huddersfield, Kirklees, United Kingdom Thornton Ross Full time
About the Role

We are seeking an experienced Regulatory Team Lead to join our team at Thornton & Ross, a leading producer of OTC medicines, generics, and specialty medicines. As a key member of our Regulatory Affairs team, you will be responsible for leading a small team of professionals in end-to-end product lifecycle management, ensuring compliance and maintenance plans are in place.

Key Responsibilities
  • Lead the Product Lifecycle Management team, overseeing workload management and development of team members.
  • Work with key partners across the business as the Regulatory lead on high-profile licensed medicines projects, including compliance programs and new product developments.
  • Develop and implement regulatory strategies for all life-cycle management activities, aligning stakeholders and delivering projects in line with agreed business plans.
  • Engage with regulatory authorities to agree submission strategies and resolve issues.
  • Prepare and submit dossiers to achieve timely authority approvals.
  • Represent the company at industry regulatory meetings.
  • Perform dossier review and gap analysis in support of product acquisition.
  • Monitor changes in legislation and proactively manage their impact on the business.
  • Strengthen ways of working within the Regulatory function and across the business.
About You

We are looking for an experienced and enthusiastic Regulatory Affairs professional with a strong track record in coaching and mentoring team members. You will have a Life Science degree or equivalent and experience working in a global regulatory team within the pharmaceutical industry. You will also have a strong working knowledge of applicable EU and UK regulations, directives, and guidance across licensed medicines.

What We Offer
  • A recently renovated work environment based in the Colne Valley.
  • Private healthcare cover.
  • Annual bonus scheme.
  • 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
  • Hybrid working options (3 days a week on site) and some flexibility to suit your preferred working pattern based around our core hours.
  • Company Pension Scheme.
  • Life Assurance (up to 3 x annual salary).
  • Discounted bus and rail travel throughout West Yorkshire and the surrounding area.
  • Free on-site parking with electric vehicle charging points.
  • Reimbursement of professional fees, where essential to the role.
  • We promote good physical and mental health and can provide additional support to our employees via our Employee Assistance Programme all year round.