For our client, a globally acting biopharmaceutical company with headquarters in the German speaking part of Switzerland, we are looking for a
DRA Project Manager (m/f)
Your main job responsibilities are:
- Elaborating international regulatory strategies for new products
- Supporting of product life-cycle management with respect to regulatory issues
- Identification of regulatory issues and critical assessment of those issues
- Representation of DRA in internal committees and meetings as well as at authorities
- Assuring regulatory compliance and staying up to date on the latest regulatory requirements
- Critically asses all international PR material
- Work closely with the DRA partner based in the USA for regulatory considerations, key regulatory documents and strategy
- Cooperate with the international DRA project manager to make sure that the support and communication for other countries is ensured
- If needed lead and establish regulatory sub-teams in terms of communication of plans and constant updates
- Ensure that consolidated interpretations of relevant Health Authority regulatory guidelines for the development andapproval of new drugs including the management of the product life-cycle are provided
- Guidance of the international submission planning process, verification and conclusion of key regulatory documents intended for submission to HA's
- Degree in life science, preferably a PhD
- Min 5 years of regulatory experience within an international environment
- Extensive experience and knowledge with NCA and EMA in EU incl. coordinating and managing meetings for scientific advice
- Comprehension of the regulatory tasks at different phases of development, from entry-into-man to activities after the approval
- Acquaintance with clinical trial methodology and statistics
- Familiar with different forms of EU submissions
- Excellent project management skills
- Very good communication skills, teamplayer and able to prioritize
- Fluent in English (oral & written)
To apply for this position, please use the application button below.
If you have further questions, Mrs. Dr. Waltraud Bueb, Managing Director, will be happy to assist for this position.
To ensure a speedy processing of your application, we would like to ask to send us your complete application documents (CV, job references, certificates, diplomas).
nemensis ag, the human factor. Your competent recruitment partner, specialized in chemistry, biology/ biotechnology, pharmaceutics, medical device/engineering or health care.
Frau Dr. Waltraud Bueb
061 205 98 98