Regulatory Affairs Specialist

3 weeks ago

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

We are seeking an experienced Regulatory Affairs professional to join our dynamic team at Thornton & Ross, a leading producer of household pharmaceutical products. As a key member of our Regulatory Affairs team, you will play a crucial role in supporting the delivery of our strategic vision of Caring for People as a Trusted Partner.

Key Responsibilities
  • Work with key partners across the business as the Regulatory lead on high-profile licensed medicines projects, including NPD and key maintenance initiatives.
  • Support new and existing product maintenance by preparing comprehensive regulatory strategies, aligning stakeholders, and delivering projects in line with agreed business plans.
  • Engage with regulatory authorities and trade associations to ensure compliance with regulatory requirements.
  • Perform dossier review/gap-analysis in support of product acquisition and prepare and submit dossiers to achieve timely authority approvals.
  • Provide Regulatory support on our Biosimilars and Speciality product portfolio.
About You

We are looking for a self-starter with strong project management skills, a well-developed understanding of commercial drivers and regulatory strategies, and the ability to partner effectively with a wide variety of global stakeholders. You will have a relevant Life Sciences degree or substantial experience in medicines Regulatory work, including managing the registration and life-cycle management of product files. Experience with document management systems, publishing software, and licensing databases/submission portals is also essential.

What's in it for you?

We offer a range of fantastic benefits, including an opportunity to further develop your medicines Regulatory experience, a recently renovated work environment, 25 days annual leave, hybrid working options, and a company pension scheme. We also promote good physical and mental health and provide additional support to our employees via our Employee Assistance Programme.

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