Head of Regulatory, Cell and Gene Technologies
United States, Houston (Texas)
United States, Lexington (Massachusetts)
United States, Portsmouth (New Hampshire)
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, Cell and Gene Technologies will provides strategic and technical regulatory leadership, expertise and advice to the Cell and Gene Technologies (CGT) Business Unit and related internal and external customers. Will lead professional RA staff in field of expertise across the Lonza CGT network. This individual will develop and maintain high level contacts with external RA stakeholders including customers, regulatory authorities, academic institutions and scientific experts in regulatory. Responsible for developing and maintaining relationships among the Lonza worldwide RA function.
- Provides RA input into Business Unit Strategy
- Anticipates, evaluates and influences (both internal and external) of global regulatory trends and legislation
- Works collaboratively with appropriate company personnel to co-ordinate the regulatory work stream elements for CGT products.
- This will include:
- Preparation and review of scientific and technical information.
- Regulatory strategy for cell and gene therapy products and all communication on such matters with regulatory authorities
- Scientific advice meetings and regulatory strategy
- Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions
- Manages the regulatory team covering CGT functions
- Provides internal regulatory support for the operation and support of the CGT BU
- Interprets applicable EU, US and other global regulatory requirements
- Acts as regulatory contact in direct communication with regulatory agencies
- Fosters good relationships with regulatory bodies
- Supports site-specific regulatory documents and activities
- Update CGT Business Unit, site and functional leads and maintain transparency of information across regulatory function
- Provides regulatory support for deviation and change control activities, as appropriate
- Acts as the CGT BU lead for all regulatory affairs activities
- Maintains a documented strategic plan for CGT Regulatory Affairs
- Coordinates implementation of activities aligned with the strategic plan
- Leads harmonization efforts for CGT Regulatory Affairs best practices
- Contributes to Global Regulatory Affairs initiatives
- Responsible for regular reporting to the CGT and Global Regulatory Affairs in line with agreed best practice
- Facilitates and support the development and documentation of revised regulatory processes in line with global processes within the LPB RA team
- Responsible for budget development, financial reporting and planning and staffing plans
- Masters Degree or PHD in an academic field related to health sciences such as biological sciences, chemistry, biochemistry, or equivalent education and at least 15 years of experience in the industry
- 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 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.