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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 Recruitment@ndareg.com 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.
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
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