Regulatory Affairs Associate Director

hace 2 días

Girona, Gerona, España Sandoz A tiempo completo
Job Title: Regulatory Affairs Associate Director

Sandoz is seeking a highly skilled Regulatory Affairs Associate Director to lead our team in ensuring compliance with global regulatory standards. As a key member of our regulatory affairs function, you will be responsible for driving and delivering high-quality documentation to support successful submissions.

Key Responsibilities:
  • Lead and coach associates to ensure regulatory competence and compliance.
  • Develop and implement regulatory strategies to maximize business benefit while ensuring compliance with global regulatory standards.
  • Coordinate the preparation and execution of regulatory documents, including CMC submissions.
  • Provide regulatory guidance to cross-functional teams and determine regulatory impact for changes in chemistry, manufacturing, and control procedures.
  • Stay up-to-date with regulatory guidelines and requirements in all global regions and new technical trends.
Requirements:
  • PhD in natural science (chemistry, pharmacy, biology, or related substances) with at least 3 years of post-doctoral/industrial experience or Master/BSc in natural science with at least 3 years of work-related experience, including people management experience.
  • Leadership experience within regulatory affairs function.
  • Broad knowledge of Module 3 and regulatory guidelines.
  • Good knowledge of relevant software tools and presentation skills.
  • Fluent oral and written English and Spanish.

Sandoz is a leading generic and biosimilar medicines company. We are committed to delivering high-quality medicines to patients worldwide.

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