Manager, Regulatory Affairs

Vor 5 Tagen

Visp, Schweiz Lonza Group Ltd. Vollzeit
Manager, Regulatory Affairs

Location: Basel or Visp

Hybrid working pattern: 2 WFH

Relocation support: Provided – subject to criteria

Today, Lonza is 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. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.

The role:

The Regulatory Affairs Manager, as part of Lonza CMO/CDMO Regulatory Affairs Biologics department, will support Customer activities focusing on chemistry manufacturing and controls (CMC) for Biologics projects. You will work collaboratively with company personnel to coordinate the regulatory activities for clinical development (e.g. IND/IMPDs), product license applications (e.g. BLA/MAA), and life cycle management activities.

Key responsibilities:

  1. Author/review the Module 3.2 dossier sections to support Customer filings for Biologics early phase projects (e.g. IND/IMPD), commercial projects (e.g. BLA/MAA), and life cycle variations submission for DS, DP, and Appendices.
  2. Represent the Regulatory Affairs department in the project team and lead submission-related activities ensuring deliverables according to project timelines and Lonza procedures.
  3. Track and negotiate within project teams source documents availability required for submissions.
  4. Prepare and review responses to Health Authority submission review questions (RtQs).
  5. Preparation and review of briefing documents for scientific advice meetings with Health Authorities.
  6. Attend Customer meetings and provide regulatory advice for assigned projects.
  7. Communicate and escalate risks and issues to management and project teams as applicable.
  8. Perform Regulatory assessments for deviations, change controls, and VCNs to ensure compliance with internal procedures and regulations.
  9. Maintenance of Lonza sites facility registration filings with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA).

Key requirements:

  1. Master's degree in Biology, Chemistry, Biochemistry, Pharmacy or equivalent. Higher education (PhD, PharmD) or Regulatory Affairs Certification (RAC) preferred.
  2. Experience (at least 5 years) in preparing and authoring M.3.2 CMC dossier sections for DS, DP, and Appendices through the product life-cycle.
  3. Previous experience in CMO/CDMO environment is a clear advantage.
  4. Extensive experience in leading project teams to successful filings and approvals.
  5. Expertise in ICH guidelines and EU and US regulatory requirements for Biologics.
  6. Knowledge/experience of Biologics manufacturing processes (e.g. Mammalian, Microbial, ADCs, Vaccines).
  7. Experience in QA, MSAT, Operations, Analytical Development, and Quality Control functions is a plus.
  8. Fluency in English and German is a plus.

Every day, Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.

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