CMC Regulatory Affairs Lead

We are seeking an experienced CMC Regulatory Affairs Lead to join our team at AurigaVision AG. This is a fantastic opportunity for a skilled professional to drive regulatory excellence in CMC technical activities during biological development projects.

• Develop and implement strategic regulatory plans, collaborating with cross-functional teams and stakeholders to ensure compliance with regulations and internal procedures.
• Promote a culture of regulatory excellence by providing expert guidance on CMC topics, influencing decisions, and driving innovative solutions to achieve project goals.
• Prepare and manage high-quality CMC regulatory submissions, ensuring timely responses to health authorities in line with regulations and internal standards.
• Conduct thorough regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases, maintaining accurate records and documentation.
• Cultivate strong relationships with regulatory agencies, fostering open communication and resolving issues efficiently.
• Stay up-to-date with evolving regulations and industry trends, applying this knowledge to advance regulatory strategies and policies.

To succeed in this role, you will need:

• An academic 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, with a focus on regulatory aspects and biological product registration.
• Proven ability to prepare CMC technical dossiers for EU and US markets, demonstrating expertise in regulatory requirements and procedures.
• Proficiency in English and French is required; proficiency in other languages is an asset.

As a valued member of our team, you can expect:

• A competitive salary ranging from CHF 80,000 to CHF 110,000 per year, depending on experience.
• A dynamic and supportive work environment that fosters growth and learning.
• Opportunities to contribute to cutting-edge projects and make a meaningful impact in the field of biotechnology.
• A comprehensive benefits package, including health insurance, retirement savings, and paid time off.