Regulatory Affairs Manager

Vor 3 Tagen

Zürich, Zürich, Schweiz Real Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

Regulatory Affairs Manager

Duration:
months)
Location:
Zurich , CH (occasional on-site presence)

Objectives

  • Support regulatory activities related to the development, registration, and life cycle management of vaccine candidates in Europe.
  • Manage assigned regulatory projects, including dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region.
  • Ensure all necessary applications are filed and maintained in compliance with applicable regulations.
  • Provide regulatory oversight for assigned clinical trials conducted in the region.
  • Collaborate with global regulatory counterparts to ensure alignment and execution of global regulatory strategy.
  • Lead and direct work within a matrixed organization with a strong focus on quality.

Accountabilities

  • Work closely with regional regulatory leadership to ensure alignment and execution of regulatory strategies during file preparation, submission, review, approval, and life cycle management.
  • Manage content, compilation, and timely availability of CTD Module 1 regulatory components for assigned regions/countries, ensuring compliance with local requirements.
  • Support local regulatory filings (e.g., MAA, MA variations) and contribute to local label development.
  • Ensure compliance with internal processes and regional regulatory requirements.
  • Prepare for health authority interactions/meetings as applicable.
  • Manage submission components in the Electronic Document Management System (EDMS) and ensure proper filing and archiving of regulatory documentation.
  • Maintain regulatory archives and comprehensive chronology files for vaccine projects.
  • Track regulatory activities and commitments in internal systems.
  • Actively participate in global regulatory teams and manage planning/execution of regulatory projects.

Education, Skills & Experience

  • Education:
    Bachelor's degree preferred.
  • Experience:
    Minimum 6 years in the pharmaceutical industry, including at least 3 years in regulatory roles or combined regulatory/vaccine-related experience.
  • Proven experience managing EMA filings via Centralised Procedure or multiple programs in related development areas.
  • Vaccines and/or biologics experience is essential; global regulatory filing experience is a plus.
  • Strong understanding of scientific issues as they relate to regulatory requirements and strategy.
  • Excellent communication skills (oral and written in English), organizational skills, and attention to detail.
  • Ability to work effectively in global, regional, and cross-functional teams.
  • Strong negotiation skills, adaptability, and integrity.

*The candidate must hold a EU passport or valid Swiss Work Permit*

SThree_Germany is acting as an Employment Business in relation to this vacancy.

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