Regulatory Affairs Director for Small Molecules
vor 2 Wochen
At Lonza, we're committed to improving lives through science. As an Associate Director, Regulatory Affairs Small Molecules, you'll play a crucial role in providing regulatory guidance to internal and external customers for our Small Molecules business.
Key responsibilities include:
- Partnering with stakeholders to prepare high-quality CMC submissions that meet regulatory criteria and align with corporate objectives.
- Overseeing regulatory CMC aspects of programs, providing guidance, and ensuring the submission of CMC documentation.
- Reviewing and evaluating the regulatory impact of change requests for the Small Molecule Drug Substances and Drug Products manufacturing process.
- Submitting country-specific health authority supporting documents, such as Drug Master Files and Site Master Files.
- Utilizing prior analytical and/or manufacturing process experience to question and propose alternative solutions to challenges.
Key requirements include:
- A degree in chemistry, biology, biochemistry, pharmacy, or equivalent.
- Extensive experience in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules.
- Experience in leading small groups and complex programs.
- Exceptional communication and writing skills, fluency in English and German.
We're looking for a talented individual who can make a meaningful difference in our organization. If you're passionate about regulatory affairs and have a strong background in small molecules, we encourage you to apply.
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