Manager, Regulatory Affairs

Manager, Regulatory Affairs

Lonza

Visp, Switzerland

In this exciting role, you will support clinical trial and product license applications for various CMC (Chemistry, Manufacturing and Control) projects for customers. You will work collaboratively with company personnel to co-ordinate 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:

  • Provide regulatory advice to customers;
  • Provide regulatory support for projects and project teams;
  • Write/review CMC sections for regulatory documents;
  • 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.

Key requirements:

  • Master or Bachelor degree in Life Sciences (e.g. Biology, Biochemistry, Pharmacy) or above;
  • Experience 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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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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