Regulatory Affairs

• Location:
  MECHELEN

#22772

Regulatory Affairs

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.

Let’s look together at your first challenge with us!

Scope of work:

• Input in development, post-approval and Life cycle management
  • Participate in global regulatory team meetings as appropriate
  • Advise the Regulatory team on applicable regulatory requirements, project specific
    regulatory issues as assigned
  • Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area
• Liaison with Regulatory Agencies and Local Operating Companies
  • Act as back-up for contact with Regulatory Agencies as needed
  • Draft cover letters for Regulatory Agency communication
  • Assist in the preparation of meetings with Regulatory Agencies
  • Liaise with LOCs, track and respond to queries in a timely manner
• Input in document and process development
  • Assist in development of processes related to regulatory submissions
  • Draft and review some document content (depending on level of regulatory knowledge /expertise)
  • Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
  • Track dates of submissions and Regulatory Agency responses
• Clinical Trial Applications (CTA)
  • Review protocols and ensure alignment with regulatory requirements
  • Advise team on required documents and submission strategies in preparation of CTAs
  • Ensure CTA submission packages are complete and available according to agreed
    timelines
  • Review and approve clinical trial supply plans
• Marketing Authorization Applications (MAA)
  • Provide regulatory support throughout registration process
  • Provide regulatory support throughout life-cycle management
  • Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
  • Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
  • Assist with submission and acceptance of MAA
  • Ensure country-specific submission packages are made available to the LOCs in
    accordance with agreed plans
  
  

Profile:

• You hold an University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
• You have experience in regulatory affairs
• You have teamwork experience
• You have project management skills
• You have oral & written communication skills
• You have organization & multi-tasking skills
• You have knowledge of the regulatory environment, guidelines and practice of EMEA regions

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

Are you interested? Apply now!