What are the responsibilities and job description for the Manager, Regulatory Affairs CMC position at Lonza?
Today, Lonza is a global leader in life sciences operating across five continents. Wile 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.
Key Responsibilities:
- Provide regulatory & strategic mentorship (Regulatory Plans) to internal and external customers for our Drug Product business in Bend (US).
- Collaborate with collaborators, customers, and team members to prepare (write and/or review) high-quality CMC submissions that meet regulatory criteria set by Health Authorities like FDA, Health Canada, EMA, and/or other regulatory bodies, while aligning with corporate objectives and relevant legislation.
- Proactively coordinate the regulatory CMC aspects of programs, providing mentorship and authoring Dossiers. Ensure the submission of CMC documentation supporting clinical trial applications and marketing submissions is in alignment with the development phase.
- Review and evaluate the regulatory impact of the change requests for Drug Products manufacturing processes, including 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.
- Apply previous experience in Quality Control, Analytical Development, manufacturing process, Quality Assurance, or Program Management to suggest alternative solutions to challenges from internal and external customers.
- Apply a solution and service-minded proactive approach even with challenging customers.
- Support the US Regulatory Affairs Drug Product Lead in Tampa.
- Perform other duties as required.
Key requirements:
- Degree in chemistry, biology, biochemistry, pharmacy, or equivalent experience.
- Extensive experience in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules, with additional understanding of large molecules being advantageous.
- Exceptional communication and outstanding writing skills, proficiency in English (additional languages are advantageous).
- Proactive, problem-solving attitude, with a strong dedication to regulatory excellence and a passion for driving healthcare innovation.
- Independent, self-motivated, organized, able to multi-task, skilled in communication with the capability to excel in a dynamic, cross-functional matrix environment.
- Great teammate who is prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
- Successful candidates must be able to learn quickly and work independently in a fast-paced environment.
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.
