Regulatory Affairs Director (m/f) - DE-BE-LU
DE-BE-LU, - full-time - 12.05.2021

Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA. At Flen Health, we are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.

We expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the results of your work, whether individually, as a team or company wide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working eco-system, enthusiastic colleagues, and an attractive remuneration package.

Regulatory Affairs Director is responsible to plan, guide, or coordinate regulatory affairs activities of the organization to ensure that Flen Health products are in compliance with regulations and standard operating procedures in existing countries where the focus is on EU and medical devices and in new countries where a focus is on the FDA and biologics. The regulatory director manages her/his team and provides responses to regulatory agencies regarding product information or issues.

Your profile and qualifications:

  • University degree in pharmacy or other healthcare-related university degree combined with relevant knowledge in biologics and semi-solid formulations through experience
  • 7+ years of working experience in the field of regulatory affairs in a pharmaceutical environment
  • In depth knowledge in applicable laws and standards such as EU MDR, c-GMP, CBER regulations, ICH, GMP, GDP
  • English (professional skills), Dutch, French or German is an asset.
  • Empathic team player
  • Leading by example
  • Excellent planning and organizational skills
  • Assurance of keeping applicable timelines
  • Result-oriented
  • Good interpersonal communication skills with team members and with relevant authorities        
  • Excellent written communication skills  
  • Builds trust within the team and across teams
  • Maintain positive attitude with other team members and sales staff
  • Builds enthusiasm to achieve common goals
  • Goes the extra mile
  • Accountability
  • Proficient in collaborating with external parties
  • Excellent skills in regard to keeping of records and data collection
  • Excellent planning and organizational skills
  • Proactive attitude

Your responsibilities:

  • Responsible for Flen Health’s product registration submissions, such as, FDA submissions, EU notified body submissions and other regulatory documents in collaboration with quality department where needed.
  • Advise in market access strategies and Pharmacoeconomics.
  • Responsible for compliance with the ethical codes of conduct and of transparency guidelines related to Flen Health products and fields of activity integrating ethical codes from legislative bodies and Flen Health vision on ethical conduct in collaboration with HR.
  • Develop and implement regulatory strategies that ensure that products, procedures and policies meet and continue to meet applicable regulations in the countries where Flen Health commercializes its products.
  • Serve as an internal resource to address and resolve any questions or issues of a regulatory nature.
  • Responsible for reimbursement files in close collaboration with the Sales/Marketing department
  • Vigilance: investigation of vigilance cases and reporting to the relevant authorities according to applicable legislation and company SOPs
  • Can act as Person Responsible for Regulatory Compliance or as back-up

What we offer:

  • Excellent working conditions
  • An innovative and inspiring work environment
  • Independent project work & responsibilities within a professional team
  • Career prospects
  • Learning and development opportunities
  • Competitive remuneration according to experience  

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

Please send your CV and covering letter by using the form below:

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