Become a Regulatory Affairs Consultant with Alsinova in Belgium, where you'll support pharmaceutical clients in navigating regulations and ensuring compliance for their products. This pivotal role involves both big pharma and small biotech projects.
Your mission will include overseeing product registration and guiding clients through complex regulatory landscapes. You will provide expertise in submitting regulatory documents and collaborating with cross-functional teams to support product launches. Your analytical skills and technical writing abilities will be essential in addressing health board inquiries and regulatory variations.
Key Responsibilities: • Facilitate clear communication of regulatory requirements • Author CTD, BLA, and NDA submissions • Collaborate with internal teams for high-quality submissions • Respond to regulatory inquiries promptly • Assess regulatory impacts of post-approval changes