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 or Principal Consultant
Team: Regulatory & Strategy Europe
Reporting to: Monika Eck-Schaupp – VP Regulatory & Strategy Europe
We are looking to expand our European Regulatory & Strategy team with a Senior or Principal Consultant in Regulatory Affairs who has experience working on a variety of programs including, small molecules, biologics or gene and cell therapy. Experience in oncology and/or rare diseases is a plus.
The position can be based with any of our European offices which are in Munich, Germany, Upplands Väsby, Sweden or Leatherhead, UK.
As a Senior or Principal 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 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 requirements
- Direct interaction with European regulatory agencies (EMA, national competent authorities in the EU, MHRA, Swissmedic)
- Expertise in a specific area of development: Regulatory Affairs, CMC, Nonclinical or Clinical
- Extensive expertise with regulatory related development procedures (e.g., Paediatric Development Plans, Fast Track, Breakthrough, PRIME or Orphan Drug Designation).
- Knowledge of ex-European regulatory procedures is desirable, but not required
- Proven ability to lead 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 complex client projects in a fast-changing international environment.
Application & Contact
Send your application (CV and letter) to Recruitment@ndareg.com with the subject line: Regulatory affairs consultant 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.
Let's Bring Medicines to the World