Regulatory Affairs Director

21 hours ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

Clinical Professionals Limited is seeking an experienced Regulatory Affairs Director to join their team. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives, and early market access.

As a Senior Regulatory Professional, you will lead client projects, preparing regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications, investigational new drug applications, PIPs/PSPs, PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications.

The estimated salary for this role is £130,000 + Benefits. The location of the job is Cambridge, UK – Hybrid, requiring 2/3 days on site per week.

The ideal candidate will have at least 12+ years in Regulatory Affairs within a complex therapeutic area, with experience in dealings with the EMA (scientific advice, orphan designation, PIPs) and driving global Regulatory Affairs Strategies.

About the Role
  • Lead client projects, providing strategic regulatory advice
  • Prepare regulatory submission documents
  • Provide leadership to a team of regulatory affairs professionals
  • Lead regulatory agency interactions/negotiations


  • Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

    At Clinical Professionals Limited, we are collaborating with a prestigious global drug development consultancy business. This esteemed organisation specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. They have a specific focus on advanced therapies, cell therapy, ATMPS, and other niche and challenging...


  • Cambridgeshire and Peterborough, United Kingdom Cpl Healthcare Full time

    Cpl Healthcare is collaborating with a prestigious global drug development consultancy business to fill the role of Senior Director Regulatory Affairs Leader. The position offers an attractive salary package of £130,000 + Benefits.Based in Cambridge, UK – Hybrid, this senior leadership role requires an office presence (2/3 days on-site per week) due to...


  • Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

    Estimated salary: £80,000 - £100,000 per annum.About Clinical Professionals LimitedWe are a leading provider of pharmaceutical and biotechnology expertise, supporting the translation of science into medicinal products. Our team is passionate about delivering high-quality services that meet the needs of our clients.Job DescriptionAs an Associate Director,...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time €130,000

    Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Location: Cambridge, UK – Hybrid Remuneration: £130,000 + Benefits Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time €130,000

    Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Location: Cambridge, UK – Hybrid Remuneration: £130,000 + Benefits Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug...


  • Cambridgeshire and Peterborough, United Kingdom ELP Consult Full time

    Job Title: Regulatory Affairs ManagerJob DescriptionAs a Regulatory Affairs Manager at ELP Consult, you will be responsible for ensuring that our operations comply with regulatory requirements and internal policies. This role involves developing and implementing compliance policies and procedures, reviewing internal processes, and providing compliance...


  • Cambridge, Cambridgeshire, United Kingdom AstraZeneca Full time

    The Head (Senior Director) International CMC Regulatory Affairs reports to the Executive Director, International Regulatory Strategy and is accountable for leading a team of regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy, delivery, and execution of international CMC Regulatory strategy...


  • Cambridgeshire and Peterborough, United Kingdom Aspire Pharma Limited Full time

    As a Regulatory Affairs Specialist at Aspire Pharma Limited, you will play a vital role in ensuring the company's pharmaceutical products meet regulatory requirements. With a highly diversified portfolio of over 250 products, this position demands attention to detail and strong communication skills.The Role:Submission and maintenance of regulatory...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job Purpose As an Associate Director, Regulatory Affairs, you are an integral part of MoonLake’s team and will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s). You will be responsible for regulatory aspects related to product development and approval, in alignment with the global...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time €130,000

    Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Cambridge, UK – Hybrid Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities. The business has a specific...


  • Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

    We are looking for a Global Regulatory Leader to support our team in Cambridge, UK. As a key member of our Regulatory Affairs team, you will play a vital role in shaping our clients' regulatory strategies and ensuring compliance with relevant regulations.The successful candidate will have extensive experience in Regulatory Affairs, particularly in dealing...


  • Cambridge, Cambridgeshire, United Kingdom AstraZeneca Full time

    The Head (Senior Director) International CMC Regulatory Affairs reports to the Executive Director, International Regulatory Strategy and is accountable for leading a team of regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy, delivery, and execution of international CMC Regulatory strategy...


  • Cambridgeshire and Peterborough, United Kingdom Boydconsultants Full time

    Job Description:We are looking for a highly experienced Senior Regulatory Professional to join our award-winning regulatory team at Boydconsultants.The ideal candidate will have a strong background in regulatory affairs, with excellent knowledge of regulatory guidelines and practices.Key Responsibilities:Work with and deputize for the Vice President,...


  • Peterborough, Cambridgeshire, United Kingdom Clinical Professionals Limited Full time €85,000 - €110,000

    Associate Director, Regulatory Affairs Job Type: Permanent Associate Director, Regulatory Affairs Job Type: Permanent, full-time Cambridge, UK – Hybrid/Remote An opportunity to join a growing business that supports pharmaceuticals, biotechs, spin-outs and academic groups to translate science into medicinal products. In this role as an Associate...


  • Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time

    ARA-P3-12 Job Title: Regulatory Affairs & Systems Data Manager Location: Cambridge (Hybrid/Flexible) Job type: permanent At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. The Manager will be...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. and BT7480, a...


  • Cambridgeshire and Peterborough, United Kingdom Aspire Pharma Limited Full time

    Job SummaryAspire Pharma Limited is seeking a highly skilled Technical Project Manager to join our team. In this role, you will play a crucial part in supporting our Research and Development department with procurement, product development reports, and collaboration with external partners.The ideal candidate will have excellent project management skills,...


  • Peterborough, Peterborough, United Kingdom Niijkiwendidaa Anishnaabekwewag Services Circle Full time

    Salary: $80,000 - $110,000 per yearJob Description:As an Executive Leader for Indigenous Affairs, you will lead the NASC team with purpose and passion, supporting and fostering positive relationships amongst the team, the Council of Directors, the community, and other partners. You will build and nurture strong and impactful relationships with community...