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Regulatory Affairs Lead for Advanced Synthesis
vor 2 Wochen
At Lonza, we recognize that our success is built on the innovative spirit and dedication of our employees. We are seeking a highly skilled and experienced Director to lead our Local Regulatory Affairs team in Advanced Synthesis.
About the RoleThe successful candidate will oversee regulatory activities for Small Molecules and Antibody Drug Conjugates Drug Substances, ensuring alignment with global and regional regulatory strategies. This includes managing a small team at site level, aligning closely with Local Leads from other sites to create a scalable regulatory framework, and acting as a liaison between local teams and regional/global regulatory leadership.
Key Responsibilities:
- Manage and coordinate regulatory activities to ensure compliance with all relevant regulations and guidelines.
- Develop and implement effective regulatory strategies to support business growth and expansion.
- Collaborate with internal stakeholders to prepare high-quality CMC submissions that satisfy critical regulatory criteria.
- Review and evaluate the regulatory impact of change requests for Drug Substances and Drug Products manufacturing process including 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.
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).
- 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.
