Job Details

A company is looking for a Regulatory Affairs CMC Author.Key ResponsibilitiesManage routine CMC authoring and submission activities for assigned products to ensure high-quality global regulatory submissionsMaintain regulatory CMC dossier templates in alignment with ICH and regional regulatory requirementsCollaborate with Global Regulatory Affairs CMC Strategists and other teams for timely preparation and review of regulatory submission documentationRequired Qualifications and EducationBachelor's degree in a scientific or related field; advanced degree preferred3 - 5 years of experience in regulatory affairs within the pharmaceutical or biotech industryStrong knowledge of global regulatory requirements for clinical trials and product registrationProven ability to manage regulatory submissions and interactions with regulatory agenciesExperience with maintaining submission-related systems and trackers