Regulatory Affairs Manager

Vor 2 Tagen

Zürich, Schweiz Proclinical Vollzeit

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%).

  • Manager Regulatory Affairs

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Hays (Schweiz) AG Vollzeit CHF 85'000 - CHF 120'000 pro Jahr

    # Manager Regulatory Affairs # (m/f/d) Freelance/temporary employment for a project Zurich Start date: asap Reference number: 852381/1 ### Responsibilities ### * Lead regulatory activities for vaccine projects, including submissions and lifecycle management * Prepare and manage Marketing Authorization Applications (MAA) and variations in compliance with EMA...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Zürich, Schweiz Hays Vollzeit CHF 140'000 - CHF 180'000 pro Jahr

    Location:Zurich | Contract:March–August 2026Are you passionate about shaping the future of vaccines? Join the Regulatory Affairs Vaccines team of our globally renowned client and play a key role in driving regulatory strategies across Europe.What you'll do:Lead regulatory activities for vaccine projects, including submissions and lifecycle...

  • Regulatory Affairs Manager

    vor 1 Woche

    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 for6 monthsAre 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...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Zürich, Schweiz Proclinical Staffing Vollzeit CHF 90'000 - CHF 150'000 pro Jahr

    Regulatory Affairs Manager Salary: Highly Competitive Job type: Contract Discipline: Senior/Director & VP Location: Switzerland Zürich, Switzerland Posting date: 02 Dec Reference: Apply for this job Shortlist Shape the future of vaccines-drive regulatory excellence across Europe. Proclinical is seeking a Regulatory Affairs...

  • Regulatory Affairs Manager

    vor 1 Woche

    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...

  • Regulatory Affairs Professional

    Vor 6 Tagen

    Zürich, Schweiz nemensis ag Vollzeit

    OverviewNavigate Complex Regulatory Landscapes – Join Our Expert NetworkTalent Pool Registration: Building our Regulatory Affairs networkOpportunities: Permanent and temporary positions availableBuilding Our Regulatory Affairs Talent NetworkWe are actively building a comprehensive talent pool of Regulatory Affairs professionals for our diverse client...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zürich, Zürich, Schweiz Actalent Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    We're looking for a Regulatory Affairs Manager to play a key role in supporting the development, registration, and life cycle management of innovative vaccine candidates across Europe. You'll manage submissions, ensure compliance, and collaborate globally to bring life-changing vaccines to patients.*This is a 5 month-contract position.What You'll DoSupport...

  • Manager Regulatory Affairs

    vor 1 Woche

    Zürich, Schweiz Hays Vollzeit

    Manager Regulatory Affairs (m/f/d) Freelance/temporary employment for a project Zurich Start date: asap Reference number: /1 Diesen Job teilen oder drucken Responsibilities Lead regulatory activities for vaccine projects, including submissions and lifecycle management Prepare and manage Marketing Authorization Applications (MAA) and variations in compliance...

  • Regulatory Affairs Manager

    vor 1 Woche

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

    Regulatory Affairs ManagerDuration: months)Location:Zurich , CH (occasional on-site presence)ObjectivesSupport 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...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Zürich, Zürich, Schweiz Coopers Group AG Vollzeit CHF 85'000 - CHF 150'000 pro Jahr

    Regulatory Affairs Manager (m/f/d) Contract Start Date: 02/03/2026 Contract End Date: 31/08/2026 Requires approximately 10 % travel. Responsibilities: Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe. Manages assigned regulatory projects including support...