Associate Director Regulatory Affairs Small Molecules
Vor 2 Tagen
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are looking for an Associate Director, Regulatory Affairs Small Molecules (f/m/d) to provide regulatory & strategic guidance (Regulatory Plans) to internal and external customers for our Small Molecules business with Manufacturing sites in Bend (US), Tampa (US), Visp (CH), Monteggio (CH) and Nansha (CN).
Key responsibilities:
Partner with internal and external stakeholder for preparation (write and/or review ) of high-quality CMC submissions that satisfy the critical regulatory criteria set by FDA, EMA, and/or other significant regulatory bodies, while also aligning with corporate objectives and relevant legislation.
Proactively oversee the regulatory CMC aspects of programs, providing guidance, managing the preparation, and ensuring the submission of CMC documentation supporting clinical trial applications and marketing submissions, in alignment with the development phase.
Review and evaluate the regulatory impact of the change requests for the Small Molecule Drug Substances and Drug Products manufacturing process incl. technology transfer.
Submit country-specific health authority supporting documents such as Drug Master Files (DMFs), Site Master Files (SMF) or other records on behalf of customers
Utilize prior analytical (Quality Control, Analytical Development) and/or manufacturing process (Operation) or Quality Assurance or Program Management experience to question and propose alternative solutions to challenges by internal and external customers
A solution and service minded proactive approach should be applied even with challenging customers
Key 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
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Reference: R61140-
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