Associate Director, Regulatory CMC, Biologics

Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities. The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review.Key Duties and Responsibilities:Leads preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)Develops and drives global CMC regulatory strategies for assigned programsServes as primary regulatory CMC lead for Health Authority interactionsProvides regulatory guidance to cross-functional teamsLeads regulatory assessment of CMC changes, deviations, and investigationsApplies AI-enabled tools for authoring, review, and consistency checksDrives structured content and data traceability approachesSupports AI/digital capability developmentContributes to process improvements and innovation initiativesRepresents Regulatory CMC in governance forumsStays abreast of and adopts emerging technologies, including AI, and maintains a continuous learning mindset to strengthen regulatory CMC's decision-making and innovation.Proactively remains up to date on advances in technology, AI, automation, competitive intelligence, and changes in the regulatory environment.Knowledge and Skills:Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologicsStrategic thinking and problem solvingExcellent communication skillsAbility to lead and influence cross-functional teamsStrong planning and prioritization skillsAbility to work in a global matrixed environmentCommitment to quality and complianceMay include people management responsibilitiesDigital & AI-Enabled Regulatory CapabilitiesWorking knowledge of AI tools for regulatory document preparation and reviewExperience with structured content and data-driven authoringAbility to critically review AI-assisted outputsFamiliarity with digital submission and data integrity expectationsAbility to identify automation and AI opportunitiesEducation and Experience:Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred)8+ years of experience in pharmaceutical or biotechnology industry with a focus on biologicsExperience leading CMC regulatory submissions and HA interactions for biologicsExperience with complex or multi-product strategies preferredPay Range:$166,400 - $249,600Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io: Boston, MAType: Full time