As CMC Regulatory Affairs Specialist, you will be responsible for providing expert regulatory support on CMC technical activities during the initial registration phase of biological development projects. Your objective will be to ensure that all products comply with regulatory requirements throughout the registration process.

Your main tasks

• Develop and implement regulatory strategies in collaboration with regulatory sub-functions and teams like quality and clinical
• Prepare and manage CMC regulatory submissions, ensuring timely responses to Health Authorities, in line with regulations and internal procedures
• Conduct regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases
• Resolve regulatory issues and communicate effectively within cross-functional teams
• Provide regulatory expertise and leadership on CMC topics, guiding and influencing decisions
• Encourage innovative solutions to achieve project goals
• Share and expand CMC regulatory knowledge

Your profile

• Academic degree in Biological Sciences, Biotechnology, or a related field
• 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
• Experience in CMC technical drug development within the pharmaceutical industry
• Proven ability in preparing CMC technical dossiers for EU and US markets
• Proficiency in English and French is required 

Carmen Aczél is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).
Full discretion is guaranteed and we will gladly answer any additional questions.