Regulatory Affairs Director
vor 1 Woche
Lonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to develop innovative solutions that improve human lives. We empower our employees to own their careers, fostering a work environment that values creativity, diversity, and collaboration.
- Key Responsibilities
- Author and review Module 3.2 dossier sections for customer filings, ensuring compliance with regulatory requirements for biologics, commercial, and life cycle variations.
- Lead and coordinate submission-related activities, ensuring timely delivery of high-quality documents and adherence to Lonza procedures and good practices.
- Serve as the primary point of contact for assigned projects, providing regulatory support to internal project teams and collaborating with cross-functional teams to achieve project goals.
- Track and negotiate the availability of source documents required for clinical and commercial submissions, ensuring seamless project execution.
- Prepare and review responses to Health Authority submission review questions and briefing documents for scientific advice meetings with Health Authorities.
- Attend customer meetings, provide regulatory advice, and communicate risks and issues to management and project teams as applicable.
- Perform regulatory assessments for deviations, change controls, and VCNs to ensure compliance with internal procedures and regulations.
Key requirements include a Master's degree in Biology, Chemistry, Biochemistry, Pharmacy, or equivalent, with a preference for higher education or Regulatory Affairs Certification (RAC). A minimum of 5 years of experience in preparing and authoring CMC dossier sections is required, as well as exceptional communication and interpersonal skills, ability to work autonomously and in a team, and experience in a CMO/CDMO environment.
Fluency in English is required, with German being a plus. The ideal candidate will have experience in leading project teams to successful filings and approvals, demonstrated skills in managing project timelines and priorities, and a good understanding of regulatory requirements and biologics manufacturing processes.
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