Head of Regulatory Affairs, 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.

The Head of Regulatory Affairs is responsible for leading regulatory support for the Portsmouth Cell Therapy site and to cell and gene therapy customers. Responsible for supporting regional regulatory affairs project activities within the Regulatory Affairs function. Work collaboratively with appropriate company personnel and partners to co-ordinate regulatory work stream elements. Supports the Cell and Gene Technologies Business Unit.

Key responsibilities:

  • 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. This will include:
  • Interprets US, EU and other global regulatory requirements to support compliance in all phases of contract manufacturing of Cell and Gene Therapy products.
  • Provides technical expertise and consulting to technical and business strategies
  • Functions as the regulatory contact in all direct communication with regulatory agencies.
  • Supports site-specific regulatory documents and activities
  • Updates functional leads 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
  • Drafts and/or reviews customer IMPD/INDs and customer MAA/BLAs
  • Provides support for scientific advice meetings and development of regulatory strategy with customers
  • Works collaboratively with appropriate company personnel for the organization and prioritization of the regulatory work and CMC regulatory activities for Cell Therapy, Portsmouth products and customers.
  • Develops and maintains high-level contracts with external RA stakeholders including customers, regulatory authorities, academic institutions, scientific experts in a regulatory and Lonza worldwide RA function
  • Anticipates, evaluates and implements trends and innovation in the RA arena.

Key requirements:

  • Significant bio-pharmaceutical industry experience including relevant regulatory affairs experience (e.g. cell therapy, gene therapy, biologics )
  • Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues
  • Working knowledge of US and EU regulatory requirements for cell and gene therapy and/or biologicals
  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation
  • Proven experience of preparing and authoring IND/CTA,BLA/MAA Module 3, and the associated CTD submissions for biological products
  • Superb organizational skills and attention to detail
  • Demonstrated skills managing project timelines, priorities and work under tight timelines Detail and results orientated
  • Ability to review and critique complex technical documents
  • Strategic approach and system oriented toward goals and objectives
  • Ability to represent the company on regulatory issues both internally and externally
  • Strong interpersonal skills and ability to interact positively with all functions and levels
  • Excellent team leader as well as committed team member

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: R29129