Regulatory Affairs Specialist

vor 3 Wochen

Visp, Schweiz Lonza Vollzeit

At Lonza, we're committed to improving lives through life sciences.

As a Regulatory Affairs Specialist, you'll play a critical role in ensuring our products meet the highest regulatory standards.

  • Author and review Module 3.2 dossier sections for customer filings, ensuring compliance with regulatory requirements.
  • Lead and coordinate submission-related activities, ensuring timely delivery of high-quality submissions.
  • Act as a point of contact for assigned projects, providing regulatory support to internal project teams.
  • Track and negotiate source document availability 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.
  • Support site-specific regulatory documentation and activities, including facility registrations and plant-level documentation.

Key requirements:

  • Master's degree in biology, chemistry, biochemistry, pharmacy, or equivalent.
  • At least 5 years of experience in preparing and authoring M.3.2 CMC dossier sections for DS, DP, and Appendices.
  • Ability to work autonomously and in a team.
  • Previous experience in CMO/CDMO environment is a clear advantage.
  • Exceptional communication and interpersonal skills.
  • Experience in leading project teams to successful filings and approvals.
  • Good understanding of regulatory requirements for biologics and biologics manufacturing processes.
  • Fluency in English required, German is a plus.

At Lonza, we're committed to making a meaningful difference in people's lives. If you're passionate about regulatory affairs and want to be part of a global leader in life sciences, we encourage you to apply.

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