Head of Regulatory Affairs Personalised Medicine
United States, Portsmouth (New Hampshire)
United States, Walkersville (Maryland)
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.
We are currently looking for a Head of Regulatory Affairs Personalized Medicine to join our Regulatory Affairs team.
Responsible for all global Regulatory aspects and support related to Lonza’s PerMed organization, including strategic direction and CMC project activities
Work with the PerMed organization to help shape, establish, set and deliver the regulatory strategy required in support of the Business Unit moving forward.
Enable and deliver support for customers in respect of clinical and commercial regulatory filings and associated activities. (This also applies to instances where Lonza is the customer).
Escalating issues in an open and timely manner and taking leadership for their resolution
Drive harmonization across PerMed and wider regulatory network with regards to regulatory activities in support of sites and customers
Design and optimize processes and systems to meet customer needs, both internal and external
Significant experience in a regulated biopharmaceutical industry including, manufacturing, quality assurance, quality control (CMC), R&D and/or drug regulatory affairs.
Experience in biological manufacturing and testing with demonstrated ability to interpret and implement related quality and regulatory requirements.
Proven management experience in an EMA / FDA regulated environment, and have an excellent working knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation. Experience in implementing regulatory initiatives experience at a senior level.
Proven recent experience of preparing and authoring complex regulatory submissions for cell and gene therapy products, at least in US and/or Europe; ideally in other ICH regions as well
Working knowledge and experience of non-clinical and clinical requirements for cell and gene therapy products
Proven ability to lead, mentor and coach direct reports and teams with or without direct line responsibility.
Strong organizational skills, ability to balance multiple priorities simultaneously.
Knowledge of (c)GMP Manufacturing of biologics, drug products and cell and gene therapy products (/advanced therapy medicinal 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.
Please NOTE: The role can be based in either Switzerland or the USA (Houston, Maastricht, Portsmouth or Walkersville).