# 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 and local regulations * Ensure timely and accurate regulatory documentation and filings * Provide oversight for assigned clinical trials and related regulatory requirements * Collaborate with global and regional teams to align regulatory strategies * Support health authority interactions and meetings in the region * Maintain regulatory archives and manage documentation in EDMS * Track regulatory commitments and activities in internal systems ### Profile ### * Bachelor-s degree; solid experience in pharma, including in regulatory affairs * Proven experience with vaccines/biologics and EMA submissions * Strong understanding of regulatory strategy and scientific issues * Excellent communication, organizational, and negotiation skills * Ability to manage multiple projects and meet timelines * Team player with proactive problem-solving skills * High attention to detail and quality focus ### Benefits ### * Remote-option * Interesting assignments at renowned national and international companies