Regulatory Affairs Director for Small Molecules

vor 2 Wochen

Visp, Schweiz Lonza Vollzeit
Join Our Team as an Associate Director Regulatory Affairs Small Molecules

At Lonza, we're committed to improving lives through innovative life sciences solutions. As an Associate Director Regulatory Affairs Small Molecules, you'll play a crucial role in shaping our regulatory strategy and ensuring compliance with global regulations.

Key Responsibilities:
  • Develop and implement regulatory plans to support our Small Molecules business, ensuring alignment with corporate objectives and relevant legislation.
  • Partner with internal and external stakeholders to prepare high-quality CMC submissions that meet critical regulatory criteria set by FDA, EMA, and other significant regulatory bodies.
  • Oversee the regulatory CMC aspects of programs, providing guidance and ensuring the submission of CMC documentation supporting clinical trial applications and marketing submissions.
  • Review and evaluate the regulatory impact of change requests for the Small Molecule Drug Substances and Drug Products manufacturing process, including technology transfer.
  • Submit country-specific health authority supporting documents, such as Drug Master Files (DMFs), Site Master Files (SMFs), or other records, on behalf of customers.
  • Utilize prior analytical and/or manufacturing process experience to question and propose alternative solutions to challenges faced by internal and external customers.
Requirements:
  • Degree in chemistry, biology, biochemistry, pharmacy, or equivalent.
  • Extensive experience in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules, with additional understanding of large molecules being advantageous.
  • Experience in leading small groups and complex programs (team or matrix).
  • Experience in leading programs on behalf of internal or external stakeholders.
  • Exceptional communication and writing skills, fluency in English and German.

We're committed to creating a positive impact on millions of people through our products and services. At Lonza, we respect and protect our people and our environment. Join us in shaping the future of life sciences and making a meaningful difference in the world.

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