Regulatory Affairs Manager

Vor 3 Tagen

Zürich, Zürich, Schweiz Proclinical Staffing Vollzeit CHF 99'999 - CHF 179'999 pro Jahr

Shape the future of vaccines-drive regulatory excellence across Europe.

Proclinical is seeking a Regulatory Affairs Manager for a contract role based in Switzerland. This position focuses on supporting regulatory activities related to the development, registration, and lifecycle management of vaccine candidates in Europe. The role offers flexibility with remote work, though occasional onsite presence may be required.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  • Support regulatory activities for vaccine development, registration, and lifecycle management in Europe.
  • Manage assigned regulatory projects, including dossier preparation, Marketing Authorization Application (MAA) submissions, and lifecycle management.
  • Ensure compliance with applicable regulations for all necessary applications and filings.
  • Oversee regulatory aspects of assigned clinical trials conducted in the region.
  • Provide regulatory oversight for non-clinical and clinical aspects of drug development and approval.
  • Collaborate with global regulatory counterparts to align and execute global regulatory strategies.
  • Lead and direct work within a matrixed organization.
  • Work closely with regional and local teams to ensure alignment and execution of regulatory strategies.
  • Manage content compilation and timely availability of CTD Module 1 regulatory components.
  • Contribute to local label development and manage local regulatory components and filings.
  • Ensure compliance with internal processes, policies, and regional regulatory requirements.
  • Prepare for health authority interactions and meetings as needed.
  • Manage submission components in the Electronic Document Management System (EDMS).
  • Maintain regulatory archives and comprehensive project documentation.
  • Track regulatory activities and commitments in applicable systems.
  • Actively participate in Global Regulatory Teams and manage assigned regulatory projects and initiatives.

Key Skills and Requirements:

  • Background in pharmaceuticals, with experience in regulatory affairs or related fields.
  • Strong understanding of regulatory requirements, particularly in vaccines and biologics.
  • Experience managing EMA filings via the Centralized Procedure is preferred.
  • Proven ability to interpret scientific issues and align them with regulatory strategies.
  • Excellent communication skills in English, both written and verbal.
  • Strong organizational skills, attention to detail, and ability to manage timelines effectively.
  • Collaborative team player with the ability to work across global, regional, and local teams.
  • Proficiency in managing electronic document systems and regulatory archives.
  • Willingness to travel occasionally, including international trips (approximately 10%).

If you are having difficulty in applying or if you have any questions, please contact
Peter Duvall
at

Apply Now:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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