Regulatory Affairs Manager (Vaccines)

Randstad Switzerland; Zürich; Hybrid; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

An international pharma company in Zürich is seeking a Regulatory Affairs Manager to oversee regulatory activities for vaccine candidates. The ideal candidate should have at least 6 years of pharmaceutical industry experience, including 3 years in regulatory roles. Responsibilities include managing submissions and compliance for vaccine projects, collaborating with teams globally, and maintaining regulatory documentation standards. Applicants should possess strong communication skills in English, attention to detail, and the ability to work effectively in teams. This position offers flexible home office options within Switzerland.

Qualifikationen

• Minimum of 6 years in the pharmaceutical industry, 3 years of regulatory experience.
• Experience with EMA filings via Centralised Procedure is preferred.
• Vaccines or biologics experience is a plus.

Aufgaben

• Support regulatory activities for vaccine candidates in Europe.
• Manage regulatory projects, ensuring compliance and filing accuracy.
• Collaborate with local and global teams to align regulatory strategy.

Kenntnisse

Oral and written communication skills (English)

Negotiation skills

Attention to detail

Teamwork

Problem-solving

Ausbildung

Bachelor’s Degree

Tools

Electronic Document Management System (EDMS)

Jobbeschreibung

For our client, an international pharma company in Zürich, we are looking for a Regulatory Affairs Manager.

General Information

• Contract: temporary contract via Randstad
• Duration: 6 months
• Extension: not possible, maternity cover
• Home office: flexible (within Switzerland)
• Travel: approx. 10% (including international)

Tasks and 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 of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region
• Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
• Responsible for regulatory oversight of assigned clinical trials conducted in the region.
• Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
• Collaborates with all regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.
• Leads and directs the work of others as part of a matrixed organization.
• Close collaboration with the RAV Europe Region Head and Lead (and LOCs as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
• In cooperation with key stakeholders and RAV Europe Region Head/Lead (and LOCs as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right-first-time.
• Supports overall content and management of local regulatory components and filings e.g. MAA, MA variations. Contributes to content for local label development.
• Ensures compliance with both internal process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
• Supports RAV Europe Region Head/Lead in the preparation of health authority interactions/meetings in the region as applicable for specified projects
• Responsible for managing of submission components in the Electronic Document Management system (EDMS)
• Responsible for filing and archiving of regulatory relevant documentations/HA communications in compliance with SOPs.
• Manages regulatory archives and maintains comprehensive chronology files for vaccine projects including, but not limited to, submission documents, contact reports, correspondence, and any other documentation pertinent to regulatory records in the EDMS.
• Supports tracking of regulatory activities and commitment in the region in company systems as applicable.
• Actively participate as member of Global Regulatory Teams supporting products activities as assigned.
• Manages planning and execution of regulatory projects and initiatives as assigned.

Your Profile

• Bachelor’s Degree preferred.
• A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 6 years regulatory and/or related experience.
• Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval; or managing multiple programs in closely related development area.
• Vaccines and/or biologics experience is nice to have.
• Participation in Global regulatory filing a plus.
• Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
• Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Exceptionally strong in working and communicating well with others including global, regional, and local teams as well as cross-functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
• Excellent organization skills and sound attention to detail.
• Team player.
• Willingness to travel to various meetings, including overnight trips. Some international travel may be required.