ClinChoice - Regulatory CMC Technical Lead Consultant

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline. • Minimum of 5 years of experience in Regulatory CMC focusing on small molecule drug development. • Additional experience with biologics and Antibody-Drug Conjugates (ADCs) is highly desirable and considered a strong advantage. • Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements. • Sound knowledge of manufacturing technical transfer and comparability regulatory requirements. • Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations. • Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system. • Strong attention to detail. Ability to multi-task, stay organized and prioritize. • Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems. • Ability to work independently and in a group setting and thrive in a fast-paced environment. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! • Our Company Ethos • Our Company Ethos