Vivid Resourcing · 2 weeks ago
Executive/Senior Director Regulatory CMC
Boston, MA
Full-time
Onsite
Director/Executive
12+ years expVivid Resourcing is an innovative and fast-growing biopharmaceutical company based in Boston, seeking a Senior/Executive Director, Regulatory CMC to lead global Chemistry, Manufacturing & Controls (CMC) regulatory strategy. The role involves designing and executing global CMC regulatory strategies, overseeing submissions, and engaging with health authorities while collaborating across various departments.
EmploymentRecruitingStaffing Agency
Hiring Manager
Aaron Fernandez
Responsibilities
Develop and own the global CMC regulatory strategy for assigned programs from early development through commercial lifecycle
Provide expert guidance on CMC regulatory requirements, precedents, and evolving global expectations
Ensure strategic alignment with corporate objectives, development plans, and commercialization goals
Lead the preparation, authoring, and review of CMC modules (Module 3, Quality Overall Summary, regional requirements)
Oversee regulatory content for INDs/IMPDs, BLAs/NDAs/MAAs, supplements, variations, and global post-approval changes
Drive regulatory risk assessments and propose mitigation strategies for technical and operational challenges
Serve as a primary company representative in interactions with FDA, EMA, and other global authorities
Strategically plan and lead key regulatory meetings, including Scientific Advice, Type B/C meetings, and pre-approval discussions
Manage responses to health authority questions with scientific, high-quality, and timely communication
Collaborate closely with Process Development, Manufacturing, Quality Assurance, Analytical Development, Supply Chain, and Program Leadership
Provide regulatory input into process changes, technology transfers, comparability, control strategies, and analytical plans
Support inspection readiness and post-inspection regulatory follow-up where applicable
Lead, mentor, and develop a team of Regulatory CMC professionals (Directors, Managers, Strategists)
Foster a culture of excellence, accountability, and proactive regulatory intelligence
Establish best practices, operating procedures, and standards for high-quality regulatory deliverables
Qualification
Required
Bachelor's degree with extensive relevant experience will be considered
12–18 years of progressive experience in Regulatory CMC or CMC development within the biopharmaceutical industry
8+ years in leadership roles overseeing CMC regulatory strategy and submissions
Demonstrated success leading major regulatory submissions (e.g., IND/IMPD, BLA/NDA, MAA)
Strong track record interacting with U.S. and global regulatory authorities
Deep knowledge of global CMC regulatory requirements and ICH guidelines
Ability to translate complex technical CMC content into clear regulatory strategies
Strong leadership presence with the ability to influence across all levels
Highly collaborative, solutions-oriented, and comfortable working in fast-paced, growing organizations
Exceptional written and verbal communication skills
Preferred
Advanced degree preferred (Ph.D., Pharm.D., M.S.) in Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline
Experience with complex modalities such as biologics, mRNA, cell/gene therapy, or viral vector products is strongly preferred
Experience supporting commercial products and post-approval lifecycle management is a plus
Benefits
Bonus
Equity
Benefits
Company
Vivid Resourcing
Vivid Resourcing is a consultancy that provides recruitment, staffing, job search and employment services for various sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase