Head of Regulatory Affairs, Hayward

United States, Hayward (California)

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.

The Head of Regulatory Affairs has overall responsibility over the Regulatory function of the Hayward site reporting to the Head of Regulatory Affairs for Biologics.

The Head of Regulatory Affairs will support Regulatory Affairs CMC (biologics) project activities, work collaboratively with appropriate Lonza personnel and Customers to co-ordinate the regulatory stages of work, preparation of license and clinical trial applications, support meetings with Health Authorities and development of regulatory strategies for these products. 

Key Responsibilities:

  • Lead the Regulatory team in Hayward
  • Direct responsibility for the preparation of clinical trial applications for customers
  • Direct responsibility for the preparation of license applications for customers
  • Maintain project plans for Regulatory
  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to questions
  • Support the site on Regulatory activities and queries from Health Authorities
  • Support the site with interactions with Health Authorities
  • Work collaboratively with appropriate company personnel to co-ordinate the regulatory work stream elements for products in clinical development.  This will include:
    • Preparation and review of scientific and technical information
    • Regulatory strategy for mammalian products and communication on such matters with regulatory authorities
    • Scientific advice meetings and regulatory strategy
  • Internal regulatory support:
    • Interpretation of applicable regulatory requirements for the manufacturer to meet cGMP requirements, etc
    • Act as regulatory contact in communication with regulatory agencies
    • Support site in the review and approval of GMP documents (Change controls and deviations)
    • Provide regulatory support and advice to Hayward site

Key requirements:

  • Life Sciences graduate, educated to degree level) - Life Sciences (e.g.: biology, chemistry)
  • At least 10 Years of pharmaceutical industry experience in Regulatory Affairs department.
  • At least 2 years Management experience
  • Good understanding of regulatory requirements for manufacturer (ie biologics) in clinical and commercial phases
  • Good understanding of biologicals, specifically mammalian fermentation
  • Experience in participating in Domestic and International Regulatory interactions is required.
  • Demonstrated skills managing project timelines and leading preparation of CMC sections in projects.
  • Good organizational stills and attention to details
  • Excellent communication and interpersonal skills
  • Proficient with Microsoft Office 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 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: R43821