Regulatory Affairs Director

vor 2 Monaten


Genf, Genf, Schweiz Teoxane SA Vollzeit
Job Title: Head of Regulatory Affairs

Teoxane Laboratories, a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking a highly experienced Regulatory Affairs professional to lead our EU and US regulatory teams.

About the Role:

As Head of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies to ensure compliance with EU and US regulations. You will provide strategic expertise and leadership to our business partners and stakeholders, including R&D, Clinical, Quality, and Marketing teams.

Main Responsibilities:
  • Develop and implement regulatory strategic roadmaps to ensure compliance with EU and US regulations.
  • Provide regulatory leadership and mentorship to our EU and US regulatory teams.
  • Contribute to key strategic decisions impacting the development of global regulatory compliance processes and procedures.
  • Monitor and adapt to new EU and US regulatory requirements through our regulatory intelligence process.
  • Contribute to regulatory strategy for new product development in collaboration with cross-functional teams.
  • Oversee the compilation of regulatory submission files for new products and product changes.
  • Ensure product compliance with EU and US regulations and standards.
  • Lead preparatory activities for interactions with regulatory agencies.
  • Ensure RA excellence by supporting the establishment, maintenance, and optimization of Regulatory Affairs processes and procedures.
Requirements and Skills:
  • Minimum 10 years of experience in regulatory affairs, with a strong background in medical devices.
  • Expertise in EU and US regulations, with a focus on high-risk medical devices.
  • Strong leadership and team management skills.
  • Ability to take ownership and responsibility for actions.
  • Strong analytical and problem-solving skills.
  • Strategic thinking and leadership ability.
  • Fluency in English.


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