Senior Consultant – Regulatory Affairs Germany

Are you an experienced specialist in Regulatory Affairs within Drug Development?

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

As a Senior Consultant at NDA you will provide our clients with strategic and operational support concerning regulatory affairs within drug development on a global, national or regional level. You will manage and take part in complex and challenging projects from international and local companies within different therapeutic areas.

Location: Germany, Munich

Key responsibilities

Regulatory Strategy

  • Support clients in organisation, preparation and conduct of
    • Scientific advice procedures with EMA and national competent authorities, including preparation and compilation of briefing document.
    • Orphan designation procedures with EMA, including preparation and compilation of supportive documentation.
    • Paediatric investigational plan procedures (applications, deferrals, waivers) with EMA, including preparation and compilation of supportive documentation.
  • Provide regulatory consultancy to clients and propose registration strategies for new product developments, line extensions and product maintenance plans, including advice on contents and timing of submissions as requested.
  • Provide regulatory advice on development strategies required for drug development from early development stages through to marketing authorisation applications, variations and renewals.
  • Manage and supervise relevant contacts and meetings, respectively, with competent authorities.
  • Provide input and support with preparation of regulatory documents like IB, IMPD, IND.

Marketing Authorisation Applications & License maintenance

  • Initiate and complete marketing authorisation applications under the centralised, decentralised or national scheme, including co-ordination and management of responses to competent authority questions and post-marketing commitments.
  • Assure that content and format of registration dossiers are in line with current requirements.
  • Co-ordinate and support preparation of regulatory documents (e.g. Summary of Product Characteristics, draft prescribing information, CTD Module 2).
  • Initiate and complete licence maintenance applications (variations, line extensions, renewals) under the respective scheme.
  • Assure that content and format of CTD documentation is in compliance with current requirements and guidelines.

Qualifications

  • A university degree in a scientific discipline is mandatory, a PhD qualification is preferred
  • Work experience in the regulatory affairs environment (EU and/or US) is mandatory
  • Experience in regulatory writing (e.g. Scientific Advice Briefing Book, CTD Modules, ODD applications) is required
  • Understanding of non-clinical and clinical R&D and product life cycle management
  • Proficiency in English and ideally German language skills
  • Strong communication skills and intercultural sensitivity

Application

Send your application (CV and cover letter) in an email labelled “Senior Consultant, Germany” to recruitment@ndareg.com. Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.