Regulatory Affairs Manager

Regulatory Affairs Manager

Lonza

Verviers, Belgium

Key responsibilities:

  • Provide regulatory support for the range of products Lonza provides to Bioscience customers;
  • Monitor and maintain policies compliant with relevant regulations and guidances, coordinates investigations, prepares and submits all required reports and associated documentation, and other related functions and projects as appropriate;
  • Perform and document activities for submissions to regulatory agencies, registering products and preparing and filing the documentation for filings;
  • Coordinate recalls, notifications, adverse reaction and other safety reports to FDA;
  • Maintain schedule of filings required, submit and track agency requests including lot release and annual reports;
  • Review and approve printed material for regulated and non-regulated products. Review and disposition of non-conforming, returned and customer complaint products;
  • Review, approve all documentation associated with manufacturing, validations, change control, deviations, SOP’s;
  • Update subject matter experts and maintain transparency of information across regulatory function.

Key requirements:

  • Bachelor’s Degree or higher required in applicable science field or equivalent;
  • Regulatory Affairs Certification (RAC) Preferred;
  • 5+ years of experience working in Pharmaceutical/Biotechnology or related industry preferred;
  • Minimum 3 years of experience preparing/authoring CMC DS sections for IMPD, IND, BLA preferred;
  • Project management experience;
  • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used);
  • Fluent in French and English.

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© EuroJobsites 2022

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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