Small Molecules Expert
vor 2 Monaten
Job Summary
We are seeking an experienced Associate Director to provide regulatory and strategic guidance to internal and external customers for our Small Molecules business. The successful candidate will be responsible for preparing and reviewing high-quality CMC submissions, managing regulatory aspects of programs, and ensuring compliance with regulatory requirements.
Key Responsibilities
Partner with internal and external stakeholders to prepare and review CMC submissions, ensuring alignment with corporate objectives and relevant legislation.
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.
Apply a solution and service-minded proactive approach, even with challenging 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.
About Lonza
Lonza is a global leader in life sciences, operating across three continents. We are committed to improving lives through innovative solutions and responsible business practices. Our people are our greatest asset, and we offer a dynamic and inclusive work environment that fosters creativity, collaboration, and growth.
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