Director, Local Lead Regulatory Affairs Advanced Synthesis

Director, Local Lead Regulatory Affairs Advanced Synthesis

Lonza

Basel or Visp, Switzerland

As Director, Local Lead (Basel) – Regulatory Affairs within our Advanced Synthesis Platform you are working as Team lead in an Matrix Team structure (cross-functional, Cross- Technological and regional coordination). As strong cross-site collaboration is key to maintain a dynamic, scalable, and adaptable regulatory framework that supports fast business decisions and a customer centric approach this Role is responsible for overseeing regulatory activities for Small Molecules and Antibody Drug Conjugates Drug Substances, supporting the overall compliance at the site level for multiple sites and are ensuring alignment with global and regional regulatory strategies.

Key responsibilities:

• Manage a small team at site level that supports multiple sites and technologies within a hybrid matrix setup;
• Align closely with Local Leads from other sites to create a scalable regulatory Affairs framework that can flex with business demands;
• Act as a regulatory liaison between local teams and regional/global regulatory leadership and collaborate with Regional Regulatory Experts and Leads to implement harmonized regulatory strategies across all locations;
• Drive process efficiencies that improve speed-to-market while maintaining compliance and support urgent projects and regulatory filings to keep pace with market opportunities;
• Communicate with peer Local Leads at other sites to share best practices, resolve challenges, and improve adaptability and provide regulatory guidance to site leadership teams, ensuring alignment with overall business objectives;
• Partner with internal and external stakeholder for preparation (write and/or review ) of high-quality CMC submissions that satisfy the critical regulatory criteria set by FDA, EMA, and/or other significant regulatory bodies, while also aligning with corporate objectives and relevant legislation;
• Proactively oversee the regulatory CMC aspects of programs, providing guidance, managing the preparation, and ensuring the submission of CMC documentation supporting clinical trial applications and marketing submissions, in alignment with the development phase;
• Review and evaluate the regulatory impact of the change requests for Drug Substances and Drug Products manufacturing process incl. technology transfer;
• Prepare and submit country-specific health authority supporting documents such as Drug Master Files (DMFs), Site Master Files (SMF) or other records on behalf of customers;
• Utilize prior analytical (Quality Control, Analytical Development) and/or manufacturing process (Operation) or Quality Assurance or Program Management experience to question and propose alternative solutions to challenges by internal and external customers;
• A solution and service minded proactive approach should be applied even with challenging customers.

Key requirements:

• Degree in Regulatory Affairs, Chemistry, Biology, Biochemistry, Pharmacy or equivalent;
• Extensive experience (10 years +) in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules with additional understanding of large molecules;
• Experience in leading small groups and complex programs (team or matrix);
• Experience in leading programs on behalf of internal or external stakeholders;
• Exceptional communication and writing skills, fluency in English (additional languages like German are advantageous);
• Proactive, problem-solving attitude, with a deep commitment to regulatory excellence and a passion for driving healthcare innovation;
• Independent, self-motivated, organized, able to multi-task, skilled in communication with capability to excel in a dynamic, cross-functional matrix environment;
• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Apply Now