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Director of Local Regulatory Compliance
vor 1 Woche
Lonza is a global leader in life sciences, operating across three continents. Our company is built on the foundation of talented people working together to devise innovative solutions that help businesses improve lives. As a Director of Local Regulatory Compliance, you will play a key role in ensuring our operations remain compliant with all relevant regulations and guidelines.
About the RoleThis position involves overseeing regulatory activities for Small Molecules and Antibody Drug Conjugates Drug Substances, ensuring alignment with global and regional regulatory strategies. The successful candidate will also be responsible for 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:
- Ensure compliance with all relevant regulations and guidelines by developing and implementing effective regulatory strategies.
- 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.
