Regulatory Affairs Intern

United States, Houston (Texas)

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 actively recruiting candidates to participate in our 2022 Summer Internship program. This program is roughly 12 weeks in length and will immerse you into the culture and operations of Lonza Houston and support the administrative components of regulatory support projects for the Houston site and to cell and gene therapy customers.  Work collaboratively with appropriate company personnel and partners to organize regulatory workstream elements.  Create tools and organize relevant information under the direction of the site Regulatory Affairs team at Lonza.

Key responsibilities:

  • Reports to the Head of Regulatory Affairs, Lonza Houston. Regulatory Affairs Intern will support the regulatory affairs team and regulatory affairs project activities.

  • Contributes to the pending implementation of a global electronic Document Management System by organizing electronic documents and files to be transferred into the new system

  • Creates tools to be utilized by the Cell and Gene Therapy Regulatory Affairs team.

  • Assists in the identification of US, EU, and other regulations and guidance documents to support responses to ad hoc questions from internal and external customers.

  • Prepares documents and folders to facilitate drafting and review of Regulatory Documents.

  • Consolidates comments for document reviews when needed.

  • Supports the Regulatory Information Bulletin process by assisting with identifying new and changes to existing relevant regulations, standards, and Health Authority guidance documents.

  • Works collaboratively with appropriate company personnel for the organization’s regulatory work and regulatory activities for Houston’s products and customers.

  • Perform other duties as assigned.

Key requirements:

  • Completion of junior year (typically 90 credits) towards a B.S. degree in a related field

  • Minimum cumulative GPA of 3.0 (out of 4) required

  • Must currently be enrolled in bachelor and a graduate degree in law, governmental affairs, or similar programs.

  • Excellent verbal and written communications skills

  • Self-motivation and the ability to contribute as a team member

  • Ability to organize, plan and execute projects

  • Research and analytical skills with attention to detail

  • Preferred experience working in a GMP 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.

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 a disability, protected veteran status, or any other characteristic protected by law. 

Reference: R42277