Senior Regulatory Affairs Specialist

vor 3 Wochen

Basel, Basel-Stadt, Schweiz Lonza Vollzeit
Join Our Team as a Senior Regulatory Affairs Specialist

At Lonza, we're a global leader in life sciences with a presence across three continents. Our success is built on the collective effort of talented individuals working together to devise innovative solutions that make a real difference in the world. In return, we empower our employees to take ownership of their careers, and it's this spirit of collaboration and innovation that sets us apart.

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 submissions.
  • Lead and coordinate submission-related activities to ensure timely delivery of agreed-upon results and adherence to Lonza procedures and good practices.
  • Act as the primary 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.
  • Support site-specific regulatory documentation and activities.
  • Maintain Lonza sites' facility registrations filings with regulatory agencies and plant-level documentation.

What We're Looking For:

  • Master's degree in biology, chemistry, biochemistry, pharmacy, or equivalent. A higher education (PhD, PharmD) or regulatory affairs certification (RAC) is preferred.
  • At least 5 years of 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 as part of a team.
  • Previous experience in CMO/CDMO environments is a clear advantage.
  • Exceptional communication and interpersonal skills to interact with internal and external customers regularly in a global environment across time zones.
  • Experience in leading project teams to successful filings and approvals.
  • Demonstrated skills in managing project timelines and priorities.
  • Good understanding of regulatory requirements for biologics and manufacturing processes.
  • Fluency in English is required, and German is a plus.

At Lonza, we respect and protect our people and our environment. We strive to make a meaningful difference in the world through the innovative solutions we provide.

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