Regulatory Affairs Expert for Biologics Development
Vor 6 Tagen
As a CMC Regulatory Affairs Specialist at AurigaVision AG, you will play a crucial role in ensuring the compliance of our biological development projects with regulatory requirements. This includes developing and implementing regulatory strategies in collaboration with cross-functional teams, preparing and managing CMC regulatory submissions, and conducting regulatory assessments for CMC change controls.
Your main tasks will include:
- Designing and executing regulatory plans to meet project objectives
- Coordinating with internal teams to ensure timely submission of regulatory documents
- Providing expert advice on CMC regulations and guidelines
- Identifying and mitigating potential regulatory risks
To succeed in this role, you will need:
- A degree in Biological Sciences, Biotechnology, or a related field
- A minimum of 5 years of experience in CMC regulatory affairs or drug substance/product development
- Proven expertise in preparing CMC technical dossiers for EU and US markets
- Proficiency in English and French is required
We offer a competitive salary range of $80,000 - $110,000 per year, depending on experience, as well as opportunities for professional growth and development. If you are passionate about regulatory affairs and have a strong background in biologics development, we encourage you to apply.
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