Regulatory Affairs Manager

Join our team as a Regulatory Affairs Manager and drive innovation in healthcare at Planet Pharma.

We are seeking a dynamic professional dedicated to shaping the future of medicine. In this role you will support the development, approval, and maintenance of groundbreaking medicinal products, ensuring life‑changing therapies reach patients worldwide.

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• Manage and oversee regulatory submissions, including clinical trial and marketing applications, ensuring compliance with global and local regulatory requirements.
  
• Develop and implement regional regulatory strategies to accelerate product development and approval processes.
  
• Provide expert guidance on regulatory documents, meetings, and negotiations to optimize product registrations.
  
• Stay abreast of evolving legislation, policies, and technical guidance, communicating their impact on regional product portfolios.
  
• Support label negotiations and regulatory planning activities, influencing decisions that impact product lifecycle management.
  
• Contribute to the development of regional regulatory strategies and risk assessments, supporting products from early development through post‑marketing.
  

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• University degree in a scientific discipline with demonstrated experience in regulatory affairs.
  
• Strong knowledge of regulatory principles, policies and procedures related to medicinal products.
  
• Familiarity with legislation, registration procedures and compliance within regional and global contexts.
  
• Excellent communication skills—both written and oral—with the ability to clearly convey complex scientific and regulatory information.
  
• Ability to proactively identify potential issues and develop strategic solutions.
  
• Proven experience in navigating regional regulatory environments and collaborating effectively with cross‑functional teams.
  

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• Experience working within the biotech or pharmaceutical industry.
  
• Knowledge of drug development processes and lifecycle management.
  
• Familiarity with specialized regulatory pathways such as Orphan Drug, Fast Track or Paediatric plans.
  
• Experience in label negotiation activities and regional regulatory mechanisms.
  

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• Bachelor's degree or higher in a scientific discipline such as pharmacy, biology, chemistry or related field.
  
• Several years of experience in regulatory affairs, preferably within European or international markets, supporting both clinical and marketed products.
  

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• Willingness to travel occasionally for onsite meetings (approximately 1 day per month in Uxbridge or Cambridge).
  
• Ability to work remotely with flexibility for in‑office collaboration.
  
• Strong organizational skills, attention to detail and ability to manage multiple priorities.
  

Ready to make a difference in the lives of millions? If you are a proactive, strategic thinker with a passion for regulatory excellence, we encourage you to apply today and be part of a team that is transforming healthcare.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.