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Are you experienced in regulatory affairs on a global or local level?


Principal Consultant Regulatory Affairs - ATMPs/Biologics


As a Principal Consultant at NDA you will provide our clients with high service quality of strategic and operational regulatory consultancy services. The focus will be on CMC aspects for ATMPs/Biological medicines on a global, national and regional level. You will manage and take part in a variety of complex projects from both international and local companies.

You will be involved in interactions with clients, internal colleagues and authorities including health authorities. The work is wide-ranging, and you will have a great opportunity to develop professionally.


  • A university degree in a scientific discipline is mandatory, a PhD qualification is preferred
  • Experience in CMC, ATMPs and Biological medicines with higher degree in cell or gene therapy or time spent in research in the pharma/biotech industry
  • At least 15 years’ experience in pharmaceutical industry and/or regulatory affairs environment (EU and/or US)
  • Experience required from leadership/management of regulatory projects (e.g. CTAs/INDs, Scientific Advice, ATMP procedures, PIP, ODD, MAA/BLA/NDA, variations)
  • Understanding of non-clinical and clinical R&D and product life cycle management
  • Proficient in English language and writing skills.
  • Excellent communication skills 

We are looking for someone with high competence in the CMC aspects of ATMPs/Biological medicines. You will have strong interpersonal skills, seeing the value in teamwork and being comfortable leading complex client projects. As a person you show autonomy, independence, and proactivity in a fast-changing international work environment. You will inspire others through your dedication and passion, creating a culture of ownership and engagement.

Become a part of NDA’s growing, highly qualified team!

Application & Contact

Send your application (CV and letter) to with the subject line: Principal Consultant UK/Europe

Selection of candidates & interviews will be conducted continuously so please submit your application as soon as possible. 


Job Facts

Job Title: Principal Consultant

Location: UK/Europe

Hours: Full-time


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