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Head of Regulatory Affairs in Basel

vor 1 Woche


Visp, Schweiz Lonza Vollzeit

We are seeking a highly skilled and experienced Head of Regulatory Affairs to join our team in Basel. As a key member of our Advanced Synthesis Platform, you will be responsible for overseeing regulatory activities for Small Molecules and Antibody Drug Conjugates Drug Substances, ensuring alignment with global and regional regulatory strategies.

About the Role

The successful candidate will manage a small team at site level, align closely with Local Leads from other sites to create a scalable regulatory framework, and act as a liaison between local teams and regional/global regulatory leadership. Key responsibilities include ensuring compliance with all relevant regulations and guidelines, developing and implementing effective regulatory strategies, collaborating with internal stakeholders to prepare high-quality CMC submissions, and reviewing and evaluating the regulatory impact of change requests.

Key Responsibilities:

  • Manage and coordinate regulatory activities to ensure compliance with all relevant regulations and guidelines.
  • Develop and implement effective regulatory strategies to support business growth and expansion.
  • Collaborate with internal stakeholders to prepare high-quality CMC submissions that satisfy critical regulatory criteria.
  • Review and evaluate the regulatory impact of change requests for Drug Substances and Drug Products manufacturing process including technology transfer.
  • Prepare and submit country-specific health authority supporting documents such as Drug Master Files (DMFs), Site Master Files (SMF) or other records on behalf of customers.

Requirements:

  • Degree in Regulatory Affairs, Chemistry, Biology, Biochemistry, Pharmacy or equivalent.
  • Extensive experience (10 years +) in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules with additional understanding of large molecules.
  • Experience in leading small groups and complex programs (team or matrix).
  • Exceptional communication and writing skills, fluency in English (additional languages like German are advantageous).
  • Proactive, problem-solving attitude, with a deep commitment to regulatory excellence and a passion for driving healthcare innovation.