AD/Director, Regulatory Affairs CMC

Role: Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation for drug development in biopharma, reporting to the Executive Director. Responsibilities: develop CMC strategies, manage the creation and submission of regulatory documentation (including ROW marketing applications), coordinate responses to health authority questions, support interactions with regulators, and ensure compliance with global regulations. Qualifications: minimum 7 years in pharmaceutical/regulatory CMC functions, bachelor's degree in life sciences or related field, excellent communication and project management skills, proficiency with document management systems like Veeva, and demonstrated ability to leverage AI tools for efficiency. HighValue: involvement in biopharma drug development, with emphasis on CMC regulatory processes, global compliance, and cross-functional collaboration. Location: remote U.S. role requiring quarterly visits to San Francisco; salary range $190,000-$285,000 USD.