Manager Regulatory Affairs (m/f/d)
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
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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