Regulatory Scientist | ATMPs

Write, review, and assemble high-quality regulatory submissions, including but not limited to

  • Preparation of IND and IMPD modules
  • EMA/FDA Interactions and Correspondance

Regulatory Sciences

  • Participate in the definition and implementation of regulatory strategies for the development of ATMPs
  • Provide support for the preparation of Agency meetings (EU and US).
  • Remain current with EU and US regulatory trends and requirements. Manage regulatory risks and potential based on global regulations and guidance.

Project Management

  • As a project team member, execute the prescribed activities, adhering to strategy, timelines, and milestones.
  • Project coordination and keeping track of timelines/deliverables using project management tools.
  • Timely internal and external communications and updates.

Knowledge Management

  • Perform background research and coordinate scientific, technical, and regulatory surveillance to be performed related to the Project

The ideal candidate will possess the following qualifications


  • Knowledge of Regulatory Sciences as demonstrated through a combination of work experience and academic background.
  • Prior experience in pharma, biotech, or related life sciences industry
  • Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies preferred
  • Direct interactions with the Health Authorities is a plus
  • Good understanding of the drug development process (ATMPs is a plus)
  • BS/BA in Regulatory Affairs or Life Sciences. MS and Ph.D. are a plus.

Personal skills:

  • Strong attention-to-detail, organization/multitasking, project management (planning, scheduling, documentation, project control), teamwork, and communication (written and verbal) skills.
  • Problem-solving abilities and a self-starter.
  • Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
  • Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), and Adobe Acrobat.
  • Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others.


  • A diversified full-time permanent position within a high-potential innovative biotech company.
  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.

Please use the button above email your CV together with an adapted cover letter to Your application and related information will remain strictly confidential.