• Globally operating pharmaceutical company
  • Temporary contract for 6 months

About Our Client

Our client, an internationally renowned Pharmaceutical company is recruiting. On its behalf we are now looking for a Regulatory Affairs Manager (a) starting in March for Zurich area, to join an international team for a period of 6 months. Hybrid work model (2 days onsite).

Job Description

• Regulatory Project Management: Manage assigned regulatory projects, including dossier/MAA submissions, life cycle management, and planning/execution of regulatory initiatives for vaccine candidates in Europe.
• Regulatory Compliance: Ensure all applications, filings, and documentation comply with regional and internal regulations and SOPs, maintaining quality and accuracy.
• Clinical Trial Oversight: Provide regulatory oversight for assigned clinical trials, ensuring adherence to applicable non-clinical and clinical regulatory requirements.
• Collaboration & Strategy Alignment: Work closely with RAV Europe leadership, local offices, and global regulatory counterparts to align on regulatory strategy and execution for assigned projects.
• Regulatory Documentation Management: Manage regulatory archives, CTD Module 1 components, submission materials, correspondence, and maintain comprehensive regulatory records in EDMS.
• Health Authority Support: Assist in preparing for health authority interactions and meetings, including submission preparation and communication with authorities.
• Content Development & Local Submissions: Support development and management of local regulatory components, filings, variations, and labeling content for assigned region/countries.
• Oversight & Quality Focus: Provide guidance in a matrixed organization, track regulatory activities and commitments, and ensure quality in all regulatory communications and deliverables.

The Successful Applicant

• Degree in a life science related field preferred
• 6+ years of pharmaceutical industry experience in regulatory affairs
• Vaccine experience is a MUST
• Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval; or managing multiple programs in closely related development area.
• Participation in Global regulatory filing a plus
• Strong communication skills in English with different stakeholders
• Excellent organization skills and sound attention to detail

What's on Offer

The selected candidate will be part of a dynamic team and actively contribute to shape, develop, and drive the department for success! Hybrid work model.

Quote job ref

JN-122025-6896612

Job Function

Healthcare & Life Sciences

Specialisation

Regulatory Affairs

Industry

Healthcare / Pharmaceutical

Location

Zürich

Contract Type

Interim

Job Reference

JN-122025-6896612