Regulatory Affairs Director

vor 3 Wochen

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:

We are looking for a strategic thinker with a strong background in regulatory affairs, who can provide expert guidance on EU and US regulations and standards. As Head of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies to ensure compliance with EU and US regulations, and for leading our regulatory teams in the EU and US regions.

Main Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with EU and US regulations and standards.
  • Lead the EU and US regulatory teams in the development and implementation of regulatory strategies.
  • Provide expert guidance on EU and US regulations and standards to cross-functional teams.
  • Monitor and adapt to changes in EU and US regulations and standards.
  • Contribute to the development of global regulatory compliance processes and procedures.
  • Oversee the compilation of regulatory submission files for new products and product changes.
  • Support life-cycle management activities, including change control regulatory impact assessments.
  • Ensure product compliance with EU and US regulations and standards.
  • Lead the preparation of briefing packages 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 EU and US regulations and standards.
  • Experience in leading regulatory teams and developing regulatory strategies.
  • Strong analytical and problem-solving skills, with the ability to resolve complex regulatory issues.
  • Excellent communication and leadership skills, with the ability to work effectively with cross-functional teams.
  • Fluency in English, with the ability to communicate effectively in a global environment.

About Teoxane Laboratories:

Teoxane Laboratories is a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics. We are committed to providing high-quality products that meet the needs of our customers, and to ensuring compliance with EU and US regulations and standards.

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