Location. Basel Stücki.
Today, Lonza is a global leader in life sciences operating across five 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.
We are currently seeking a proactive and experienced Senior Regulatory Affairs Expert / Regulatory Affairs Manager to join our matrix-based Global Regulatory Affairs team in Advanced Synthesis (ADS) Basel. This role will be pivotal in supporting our manufacturing operations in ADS sites including a site based in China also providing strategic support to other global manufacturing locations. In your role within our Advanced Synthesis Platform you are working as a team member in a Matrix Team structure (cross-functional and cross- technological and cross-site). As strong cross-site collaboration is key to maintain a dynamic, scalable, and adaptable regulatory team that supports business decisions and a customer centric approach. This role is responsible for overseeing regulatory activities for Advanced Synthesis Drug Substances and Drug Products, supporting the overall compliance at the site level for multiple sites and are ensuring alignment with global and regional regulatory strategies.
This role will provide end-to-end regulatory support for products manufactured with Lonza, with a primary focus on interactions with the Chinese Health Authorities (e.g., CDE/NMPA), US-FDA and other Health Authorities.
What you’ll get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
What you’ll do:
Serve as the global RA support for products manufactured in China, acting as the main regulatory interface between Lonza, Customer and Health Authorities.
Coordinate and support Market Authorization Applications (MAA), Biologic License Applications (BLAs) and New Drug Application (NDA) submissions including stewarding third-party and partner engagements, externally, as needed for project execution.
Support cross-functional teams through robust risk assessments and strategic planning to ensure readiness and quality of regulatory submissions.
Act as a bridge between project teams and the Customers/Health Authorities, especially during and after pre-MAA, pre-BLA and pre-NDA meetings, ensuring alignment on potential deficiencies and response strategies.
Provide regulatory support for supplemental dossiers based on feedback from authorities (America, China, Europe).
Offer input on CMC-related regulatory content and ensure global and local compliance.
Support manufacturing sites outside of China as needed, providing RA input into tech transfers, variations, and lifecycle submissions.
Maintain awareness of evolving Chinese regulatory requirements and proactively advise internal stakeholders on implications for development and commercialization.
What we’re looking for:
Advanced degree in Life Sciences, Chemistry, Pharmacy, or related field.
Ability to understand and bridge cultural context and exhibit appropriate behavior to ensure successful business outcomes.
Minimum 5–7 years’ experience in CDMO Industry, with proven hands-on experience in interacting with Health Authorities.
Demonstrated ability to coordinate and negotiate with internal and external stakeholders.
Strong understanding of CMC regulatory requirements, particularly in the context of China submissions.
Experience guiding cross-functional teams in regulatory risk assessment and dossier planning.
Excellent communication and intercultural skills; able to work effectively in a global matrix environment.
Fluency in English and Chinese (incl. Mandarin, Cantonese) is required. Additional languages are an advantage e.g. German, French, Italian.
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.
