Regulatory Affairs Manager (m/f/d)
Responsibilities
- Author/review CTD module 3.2 sections for biological medicinal products
- Manage responses to Health Authority (HA) questions
- Draft/review briefing documents for scientific advice procedures
- Interact with Health Authorities
- Lead and coordinate activities to meet submission deadlines
- Perform regulatory assessments for change controls and deviations
- Support site-specific regulatory documentation and activities
- Participate in process improvement projects
Profile
- Advanced knowledge in Life Sciences and Pharmaceutical Sciences
- Strong knowledge of CMC requirements for biologics and strong organizational and project management skills
- Solid experience in authoring CMC CTD sections
- Ability to work autonomously and in a team
- Good communication and interpersonal skills.
- Analytical and learning skills.
- Previous experience in a contractor environment is an advantage
- Good knowledge of MS tools (Word, Excel, SharePoint)
- Bachelor’s or Master’s degree in relevant fields; higher education preferred. Regulatory Affairs Certification is an advantage
Benefits
- Further training opportunities
- Friendly working enviroment
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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