Reg Affairs AD - CMC Regulatory Regional Expert

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions: Office Job Description: Join Us as a Regulatory Affairs Associate Director – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to lead innovative projects and provide strategic regulatory intelligence that makes a real difference in product development. As a Regulatory Affairs Associate Director, you'll play a key role in guiding product development from preclinical stages through registration and optimization. You will provide regulatory expertise and client interface, offering strategic guidance and updates on country, regional, and global regulatory intelligence. Routinely act as an adviser to other units within the department and liaise with local country regulatory authorities. Responsible for acting as a liaison with internal and external clients in the provision and marketing of these services. What You’ll Do: Lead CMC regulatory strategy and submissions for biologicals, ensuring compliance and succe...