Nonclinical Senior Regulatory Scientist (UK, Switzerland, France)

We are currently looking for a nonclinical (NC) Senior Regulatory Scientist to author and deliver in a timely manner high quality NC and scientific documents to align with product development and registration strategy, addressing multiple client projects, including drugs, biologics, Advanced Therapy Medicinal Products (cell-, gene- and tissue therapies), medical devices and combination products.
Principal roles and responsibilities will mainly include:

• Collect and evaluate NC scientific data from client’s documents;


• Draft and/or review NC and regulatory documents including but not limited to NC study protocols and experimental reports,


• Draft and/or review NC gap analyses and development plans, investigator brochures, scientific advice briefing documents (EU and US), NC modules (2.4 and 2.6.1 to 2.6.7),


• Contribute to the review of other regulatory documents e.g. Orphan Drug Designation applications, Pediatric Investigation Plans, PRIME applications and US equivalents,


• Ensure that the documents' content and style are in-line with the required regulation standards and guidelines, and comply with either VCLS, or client SOPs / in-house style requirements;


• Contribute to update NC information database in order to enhance NC/C team knowledge (regulatory guidelines and relevant publications);


• Interact as necessary with clients during project realization and discuss/challenge as necessary NC experimental designs and models.

• A highly motivated and experienced individual with a proven track record in effective NC “hands-on” and translational experience (a minimum of 4 years);


• Proven experience required in
  
  
  
  • designing/performing and/or managing NC studies (pharmacology proof-of-concept, pharmacokinetics, and toxicology);
  
  
  • authoring and editing a large variety of NC and regulatory documents including but not limited to: NC study protocols and reports, and regulatory documents such as briefing books for scientific advice and pre-IND, sections of regulatory submissions (in particular NC modules);
  
  


• Experience with ICH guidelines and other applicable EU & US regulatory guidance;


• Experience with research tools and approaches, such as reference management/publication planning databases;


• Designing/performing and/or managing NC biocompatibility studies per ISO 10993 would be a plus


• Experience working in the CRO industry or as a consultant is a plus.


• Preparation of responses to health authorities’ questions is a plus

• Master or PhD degree in a scientific/Life Sciences discipline


• Interest and ability to work across multiple and transversal projects (CMC,clinical, and regulatory);


• Interest to interact closely with clinical consultants and experts, as part of the NC/C team,


• Ability to juggle multiple priorities and adapt quickly to new situations and new projects;


• Excellent interpersonal, verbal and written communication skills in English; French is a strong plus


• A flexible attitude with respect to work assignments and project deadlines;


• Value the importance of teamwork;


• Strong computer skills, including MS Office and Internet.

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