Regulatory Affairs Manager, Cell Therapy

United States, Portsmouth (New Hampshire)

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.

Based in Portsmouth, New Hampshire the Regulatory Affairs Manager will support the site’s and customers’ regulatory affairs and CMC project activities. This opening will reside with the expanding Cell and Gene Therapy team. 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. In this role, you will provide 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.

Key Responsibilities:

  • Site-specific activities and draft and/or coordinate the review of customer regulatory clinical and commercial filings.
  • Works collaboratively with appropriate company personnel for the organization and prioritization of the regulatory work and CMC regulatory activities for Portsmouth’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.

Key Requirements:

  • Significant experience in the bio-pharmaceutical industry experience with a Bachelor's degree of which at least intermediate level relevant regulatory affairs experience, advanced degrees preferred.
  • Biologics experience required, cell and gene therapy highly desired.
  • Expertise in the interpretation and communication of CMC regulatory requirements.
  • Working knowledge of US and EU regulatory requirements for biologicals.
  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation. 
  • Agencies and Industry trends across all areas of GXP to anticipate the needs of both the company and the customers and communication of these trends.
  • Proven experience of preparing and authoring IND (Investigational New Drug), BLA (Biologics License Application) and CTD (common technical document) submissions for biological products.

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 it is 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.

Reference: R44932