Join Our Team

Are you a dedicated and driven Regulatory Affairs professional with drug development experience? Do you want to be part of a global team and utilize your experience and knowledge to help ensure that good medicines get to those who need them without unnecessary delay?

Role: Senior Consultant - CMC Biologics

Team: Regulatory & Strategy Europe

Reporting to: Monika Eck-Schaupp – VP Regulatory & Strategy Europe

 

We are looking to expand our European Regulatory & Strategy team with Senior Consultants in Regulatory Affairs who have experience in CMC Biologics. The position can be based with any of our European offices which are in Munich Germany, Upplands Väsby Sweden or Leatherhead UK.

Responsibilities

As a Senior Consultant at NDA Group, you will provide strategic and operational regulatory support within drug development on a global, regional, or national level. You will manage and contribute to a variety of complex projects working with large international companies and small international and local start-ups.

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

Qualifications / Experience

  • A minimum of 10 years of relevant experience in European Regulatory Affairs
  • Experience in leading the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with client company policies
  • Experience and up-to-date knowledge of European regulatory procedures and changes
  • Direct interaction with European regulatory agencies (EMA, national competent authorities in the EU, MHRA, Swissmedic)
  • Expertise in CMC related requirements for biologics
  • Extensive expertise with regulatory related development procedures and requirements as relates the CMC documentation (e.g., Modules 2.3 and 3, IMPD, IND, Paediatric Development Plans, Fast Track, Breakthrough, PRIME).
  • Knowledge of ex-European regulatory procedures and CMC related requirements is desirable, but not required
  • Proven ability to lead and/or participate in cross functional European and/or global teams
  • Ability to work independently
  • Excellent communication skills 

We are looking for someone who sees the value in teamwork and is comfortable leading or contributing to complex client projects in a fast-changing international environment. 

Read more about working at NDA.

Application & Contact

Send your application (CV and letter) to Recruitment@ndareg.com with the subject line: Regulatory affairs consultant Europe CMC Biologics

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

 

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