Regulatory Affairs Manager

vor 3 Wochen

Basel, Basel-Stadt, Schweiz Lonza Vollzeit

At Lonza, we're a global leader in life sciences, operating across three continents.

Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.

We let our people own their careers, and their ideas genuinely improve the world.

As a Regulatory Affairs Manager, you'll be part of this mission.

Key responsibilities:

  • Author and review Module 3.2 dossier sections to support Customer filings for Biologics early phase projects, commercial projects, and life cycle variations submission.
  • Lead and coordinate submission-related activities, ensuring deliverables according to agreed timelines and in accordance with Lonza procedures and good practices.
  • Act as a point of contact for assigned projects and provide regulatory support to internal project teams.
  • Track and negotiate source documents availability required for clinical and commercial submissions.
  • Prepare and review responses to Health Authority submission review questions and briefing documents for scientific advice meetings.
  • Attend Customer meetings and provide regulatory advice for assigned projects.
  • Communicate and escalate 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.
  • Internal regulatory support for operation and control, including understanding of EU, US, and other global regulatory requirements.
  • Support site-specific regulatory documentation and activities, including maintenance of Lonza sites facility registrations filings with regulatory agencies.

Requirements:

  • Master degree in Biology, Chemistry, Biochemistry, Pharmacy, or equivalent.
  • Experience in preparing and authoring M.3.2 CMC dossier sections for DS, DP, and Appendices through the product life-cycle.
  • Ability to work autonomously and in team, with exceptional communication and interpersonal skills.
  • Previous experience in CMO/CDMO environment is a clear advantage.
  • Fluency in English required, German is a plus.

At Lonza, we respect and protect our people and our environment.

We offer the satisfaction that comes with improving lives all around the world.

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