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 - Clinical Development and Authoring
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 Consultant in Regulatory Affairs who has experience in working on and authoring of regulatory and clinical documentation. The projects include a variety of programs including small molecules, biologics and gene or cell therapies. Experience in development of compounds in oncology and/or rare diseases is a plus.
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 and UK 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 and UK regulatory procedures and requirements
- Direct interaction with European regulatory agencies (EMA, national competent authorities in the EU, MHRA, Swissmedic)
- Expertise in clinical development and the requirements for related clinical documentation (Modules 2.5 and 2.7, paediatric development plans, Fast Track, Breakthrough, PRIME or Orphan Drug Designation)
- Knowledge of ex-European regulatory procedures and related requirements for the clinical documentation 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.
Application & Contact
Send your application (CV and letter) to Recruitment@ndareg.com with the subject line: Regulatory affairs consultant UK
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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