Regulatory Affairs Manager m/f - USA
USA, home-based - full-time - 29.02.2020

Flen Health is an international, innovative, family-owned company based in Luxembourg, Belgium, the Netherlands, Germany and the UK.
Over the course of just a few years, Flen Health have gained the leading position in their home market, namely the Belgian wound care market and are working towards achieving this on an international level. Our company’s success is based on the dedication of our people and our safe and easy-to-use product portfolio which combines innovation with significant progress in wound care and is inspired by our motto. We help you to ‘live the life you love’.


Your profile and qualifications:

  • Minimum 5 years of experience of Regulatory Affairs in drugs

  • FDA experience is required

  • Chemical background is required

  • Demonstrated experience in eCTD compilation for topical/dermatological drugs for U.S. and/or EU submissions

  • Demonstrated ability to interact and communicate (both oral and written) with project team/ organizational members/ regulatory bodies (FDA)

  • PhD/Master’s degree in Industrial Pharmacy/Pharmaceutical Sciences or equivalent based on

    relevant experience

  • Knowledge in U.S. FDA drug regulatory requirements, preferably in the field of dermatology.

  • (Pre)-clinical background

  • Ability to read and understand FDA regulations, guidance documents, test reports and technical/chemical product information

  • Submission authoring experience

  • Self-motivated team worker who is equally capable of lone working

Your responsibilities:

  • Responsible for the creation, assembly, and publication of U.S. FDA submissions related to drugs and maintenance of these approvals
  • Regulatory project work and timeline planning
  • Adherence to required submission timelines, health authority publishing specifications,
  • relevant legislation and internal working practices
  • Maintaining a productive working relationship with external regulatory bodies (FDA)
  • Monitoring external changes to the regulatory environment to ensure continued compliance
  • Liaison with several departments in order to ensure that documents are compliant and submission-ready. Work with document authors to ensure that documents comply with current U.S. FDA regulatory guidance/template specifications
  • Provision of feedback to your line manager regarding submission progress
  • Ownership of the CTD’s submission
  • Ownership of the first eCTD within the CDER division of the FDA.

What we offer:

  • Excellent working conditions
  • An innovative and inspiring work environment
  • Independent project work & responsibilities within a professional team
  • Career prospect
  • Learning and development opportunities
  • Company Car, Laptop and Mobile which can be used privately
  • Competitive remuneration including personal benefits package
  • Variable bonus based on both Flen Health results and personal performance
  • Daily allowances, a solid company pension scheme and attractive collective health insurance
  • package
  • Healthy work-life balance such as a flexible policy to work from home. 


Are you interested in working with an ambitious and very dedicated team?

Please send your application, CV and motivation letter via the form below:

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