Regulatory Affairs Manager

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.

At our dynamic Houston site, you will have an outstanding opportunity to support regulatory efforts for cell and gene therapy. You will collaborate with internal teams and external customers, playing a crucial role in advancing therapies from concept to commercialization.

Job Description:

• Lonza is a leading CDMO with an extensive biologics clinical and commercial manufacturing network.  Lonza is rapidly expanding its role as a leading CDMO for dell and gene therapy products with a focus on supporting customers advancing promising products from concept to commercialization

• Lonza is looking for an individual to provide regulatory affairs support for cell and gene therapy customers and project teams at one of Lonza’s manufacturing sites

• The role will include 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 GMP material from clinical to commercial.

• Based in Houston, the Regulatory Affairs Manager will support the site’s and customers’ regulatory affairs and CMC project activities

• 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 IMPD/INDs and customer MAA/BLAs

• 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

• Perform other duties as assigned

• Biologics experience (note: cell and gene therapy experience preferred but not required)

• Previously responsible for the preparation and delivery of regulatory submissions

• Experience with CDMOs

Bachelor's degree or equivalent experience required.| Field of Study: Degree in Science or related discipline| Degree Preferred: Master's Degree pr Ph.D.

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.