Regulatory Affairs Manager
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
The Regulatory Affairs Manager will support the Cell and Gene Technologies (CGT) Regulatory Affairs (RA) Lonza Houston Inc (LHI) site conducting CGT programs for customers. This individual is responsible for providing regulatory support for CGT RA activities, internal projects and customer projects. Supports regulatory and compliance information, filings, schedules and requirements. The individual is responsible for designing and implementing models and templates and for gathering and assembling documents and information for submission based on those models.
- Provide technical writing, review, editing and formulating of drafts and related materials for chemistry, manufacturing and controls (CMC) sections of regulatory applications.
- Providing regulatory support for the range of services Lonza provides to cell therapy customers at all stages of development including the manufacturing and testing of Good Manufacturing Practices (GMP) material from clinical to commercial.
- Works collaboratively with appropriate company personnel for the organization and prioritization of the regulatory work and CMC regulatory activities for Houston’s products and customers
- Drafts and/or reviews customer Investigational Medicinal Product Dossier (IMPD), Investigational New Drugs (IND) and customer Marketing Authorization Application (MAA) and Biologics License Application (BLA).
- Uses available systems and tools to coordinate and track regulatory activities
- Supports site-specific regulatory documents and activities
- Updates subject matter experts and maintain transparency of information across regulatory function
- Provides regulatory support for deviation and change control activities, as appropriate
- Interprets and evaluates regulatory data to prepare documents and submissions, as appropriate
- Provides support for scientific advice meetings and development of regulatory strategy with customers
- Interprets US, EU and other global regulatory requirements to support compliance in all phases of contract manufacturing of cell and gene therapy products
- Provides regulatory support and advice for internal and external customers in line with defined regulatory plans and in response to ad-hoc question to resolve regulatory issues
- Anticipates, evaluates and implements trends and innovations in the regulatory arena
- Masters Degree or PHD in an academic field related to Health Sciences such as Biology, Biotechnology and Pharmacy
- Advanced experience in Regulatory Affairs
- Advanced experience in GMP
- Biologics experience (note: cell and gene therapy experience preferred but not required)
- Previously responsible for the preparation and delivery of regulatory submissions
- Experience with Contract Development Manufacturing Organizations (CDMOs)
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.