Regulatory Affairs Manager

Vor 3 Tagen

Zürich, Zürich, Schweiz Helvetic Payroll Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

 Zurich, Switzerland |  Full-time |  Hybrid / On-site | Start date: April 2026 for
6 months

Are you passionate about shaping regulatory strategy for life-changing vaccines in Europe?

We are looking for an experienced Regulatory Affairs Manager – Vaccines (Europe) to support the development, registration, and lifecycle management of innovative vaccine candidates across the region.

This is a unique opportunity to play a strategic role in bringing next-generation vaccines to patients, while collaborating with global teams in a highly dynamic and impactful environment.

What You Will Do

As a key member of the European Regulatory Affairs Vaccines team, you will:

- Support regulatory activities from early development through approval and lifecycle management.

  • Lead and manage assigned regional regulatory projects, including CTD Module 1, MAA support, variations, and local submissions.

  • Ensure timely, compliant, and high-quality regulatory submissions ("right-first-time").

  • Provide regulatory oversight for clinical trials conducted in Europe.

  • Drive alignment with global regulatory strategy in collaboration with global, regional, and local regulatory teams.

  • Lead preparation and documentation for Health Authority interactions.

  • Maintain regulatory archives, systems, timelines, and compliance with internal processes.

  • Work cross-functionally with clinical, non-clinical, CMC, and regional counterparts.

  • Contribute to global regulatory teams and support strategic initiatives.

What You Bring

  • Minimum 6 years of pharmaceutical industry experience, including at least 3 years in regulatory affairs (vaccines or biologics strongly preferred).

  • Experience with EMA submissions, centralized procedures, or multi-country regulatory programs.

  • Strong understanding of scientific and regulatory requirements for vaccines development.

  • Excellent communication skills in English (written & verbal).

  • Ability to manage multiple priorities, meet deadlines, and collaborate within a matrixed, international organization.

  • Detail-oriented mindset, integrity, and proactive problem-solving approach.

Why Join?

  • Work on cutting-edge vaccine programs with global impact

  • Join a highly collaborative, mission-driven international regulatory team

  • Be part of a company committed to innovation, quality, and patient well-being

  • Opportunities for ownership, cross-regional exposure, and career development

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