What's New

Lead Regulatory Affairs

Your responsabilities

Regulatory Sciences

  •  Define and implement 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.

Regulatory Submissions

  • Write, review, and assemble high-quality regulatory submissions
  • Prepare IND and IMPD modules
  • Assure EMA/FDA Interactions and Correspondance

Project Management

  • As a project team member, execute the prescribed activities, adhering to strategy, timelines, and milestones.
  • Coordinate the projects and keep track of timelines / deliverables using project management tools.
  • Assure 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

You have

Background

  • a strong knowledge of Regulatory Sciences in ATMP’S, ideally, or in biologics / vaccines / medicinal products
  • a positive similar (strategic) experience of 5 to 10 years in pharma, biotech, or related life sciences industry
  • an excellent understanding of the drug development process (ATMPs is a plus)
  • experience with regulatory submissions and interactions with (US / EU) regulatory agencies is a strong asset
  • experience in direct interactions with the Health Authorities is a plus
  • an academic background related to the requirements of the position (BS/BA in Regulatory Affairs or Life Sciences. A Ms or a Ph.D. are a plus).

Personal skills

  • strong attention-to-detail, project management (planning, scheduling, documentation, project control), teamwork, and communication (written and verbal) skills.
  • multitasking and problem-solving abilities as you will work in a small team
  • ability to work under strict 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.
  • the willingness to maintains our company values (People, Innovation, Passion, Excellence) while demanding the highest standards of conduct from self and others.

Our offer

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.
Interested?

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