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