Regulatory Affairs Specialist

4 weeks ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Fusion Pharma Limited Full time
Regulatory Affairs Consultant

We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Fusion Pharma Limited. As a key member of our Regulatory Affairs Department, you will play a crucial role in ensuring the compliance of our clients' products with regulatory requirements in the UK and EU.

Key Responsibilities:
  • Develop and implement regulatory strategies for our clients' products, including Life Cycle Management activities
  • Author and compile regulatory documents, such as CMC and safety variations, Art 61(3), PSURs, and MAAs
  • Collaborate with our clients' teams to support their regulatory needs, including representation during internal/external audits or Health Authority inspections
  • Contribute to the development of regulatory intelligence, including interpreting changes and communicating these to our community
  • Participate in business development activities, such as creating marketing materials and representing Fusion Pharma at conferences and networking events
Requirements:
  • Life Sciences degree
  • Fluent in written and spoken English with excellent communication skills and attention to detail
  • Minimum of 3 to 5 years Reg Affairs experience, aligned with our essential experience
  • Proficient in Microsoft Office applications and ability to learn new electronic systems
  • Proven competency in working autonomously and multi-tasking in a fast-paced environment
  • Commitment to representing Fusion Pharma to a high standard, face-to-face and remotely
What We Offer:
  • Competitive salary
  • Permanent and full-time position
  • Flexible working hours
  • Remote working
  • 6 weeks holiday
  • Private healthcare
  • Pension


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