Manager Regulatory Affairs (m/f/d)

☞ Randstad Switzerland

View: 146

Update day: 25-04-2024

Location: Visp Valais VS

Category: Legal / Contracts

Industry: Staffing Recruiting Biotechnology Research Pharmaceutical Manufacturing

Position: Associate

Job type: Temporary

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Job content

We are looking for a Manager, Regulatory Affairs (m/f/d) for Lonza AG in Visp or Basel Stücki (100%). This is a temporary position for 12 months, with an opportunity to extend. Remote work from within Switzerland is possible.

Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there’s no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work Lonza wants to be part of.

In this exciting role, you will support clinical trial and product license applications for various CMC (Chemistry, Manufacturing and Control) biological projects for customers. You will work collaboratively with company personnel to coordinate the regulatory activities for clinical development, product license applications as well as life cycle management. The role will also provide support for the site with respect to change control and deviation assessment and other activities such as evaluation of new projects.

Key responsibilities
  • Author/review and provide input from a CMC perspective on relevant documents required for (BLA/MAA) submission for Biologicals
  • Author/review the Module 3 section for IND/IMPD for biologicals
  • Facilitated and/or attended CMC meetings with key stakeholders and regulators when applicable (e.g. FDA/EMA) for biologicals
  • Provide regulatory advice to customers for biological projects
  • Provide regulatory support for projects and project teams
  • Prepare briefing documents for agency meetings
  • Attend customer meetings and project team meetings
  • Devise and maintain regulatory project plans in line with the best practice recommendations
  • Update functional leads and maintain transparency of information across regulatory function
  • Site support activities, e.g. perform assessments for change controls and deviations; support site specific regulatory documents
  • Master or Bachelor degree in Life Sciences (e.g. Biology, Biochemistry, Pharmacy) or above
  • Experience (at least 5 years) in preparing and authoring CMC (Chemistry, Manufacturing and Control) sections for regulatory documents through product life cycle
  • Good understanding of regulatory requirements for biologicals
  • Good practical experiences in Regulatory Affairs in a pharmaceutical environment
  • Previous experience in CMO/CDMO environment is a clear advantage
  • Demonstrated skills managing priorities and project timelines
  • Organization skills and attention to details
  • Fluent in English required; German is a plus
  • Ability to work across a complex matrix environment
  • Exceptional communication and interpersonal skills
  • Ability to remain calm under pressure
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Deadline: 09-06-2024

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