The Global Regulatory CMC Senior Consultant is responsible for supporting the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across a diverse portfolio, including small molecules, biologics, and advanced therapies (e.g., cell and gene therapy). This role collaborates cross-functionally to ensure timely, high-quality regulatory submissions and compliance with global health authority requirements throughout the product lifecycle.
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Key Responsibilities
Regulatory Strategy & Submissions
Contribute to the development and implementation of global CMC regulatory strategies aligned with clinical and commercial objectives
Support preparation and submission of global regulatory dossiers, including:
o INDs / CTAs
o NDAs / BLAs
o MAAs
o Health authority briefing packages and scientific advice documents
Author, review, and manage CMC sections of regulatory submissions, ensuring accuracy, completeness, and compliance with regional requirements
Regulatory Documentation & Compliance
Prepare and review CMC documentation, including responses to health authority questions, post-approval variations, and lifecycle management submissions
Ensure alignment of regulatory documentation with current FDA, EMA, ICH, and other global regulatory guidelines
Maintain inspection readiness and support regulatory audits/inspections as needed
Change Management & Lifecycle Support
Evaluate and provide regulatory impact assessments for CMC change controls within global quality systems (e.g., eQRMS, Infinity, Veeva/Verity)
Support implementation of post-approval changes, ensuring compliance with regional reporting requirements
Participate in lifecycle management planning for both development and commercial products
Cross-Functional Leadership
Serve as the Regulatory CMC representative on cross-functional development and commercial teams
Collaborate with functions including Manufacturing, Quality, Analytical Development, Supply Chain, and Clinical/Regulatory teams
Facilitate document review meetings and drive alignment across stakeholders
Health Authority Interactions
Support preparation for and participation in global regulatory agency interactions (e.g., FDA, EMA, PMDA), including meeting requests, briefing books, and follow-up responses
Ensure clear communication of regulatory expectations and commitments across internal stakeholders
Project Management & Execution
Manage multiple projects and timelines to ensure delivery of high-quality regulatory outputs
Proactively identify risks, propose mitigation strategies, and drive resolution of complex CMC regulatory issues
Continuous Learning & Development
Maintain current knowledge of evolving global regulatory requirements, industry trends, and best practices in CMC
Contribute to process improvements and regulatory excellence initiatives
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Qualifications
Bachelor s degree (BS/BA) in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Chemical Engineering or related field); Master s or PhD strongly preferred
10 15 years of experience in the pharmaceutical/biotechnology industry
5 7+ years of Regulatory CMC experience supporting clinical and/or commercial programs
Demonstrated experience supporting global regulatory submissions and lifecycle management activities
Required Skills & Competencies
Technical Expertise
Strong knowledge of CMC regulatory requirements across multiple regions (FDA, EMA, ICH guidelines)
Hands-on experience with:
o INDs, CTAs, NDAs, BLAs, MAAs
o Variations, supplements, and health authority responses
o Briefing documents and regulatory meeting preparation
Understanding of drug development lifecycle, including early development through commercialization and post-approval changes
Regulatory Strategy & Problem-Solving
Ability to contribute to CMC regulatory strategy development
Strong analytical skills with a solution-oriented mindset
Ability to assess regulatory risk and recommend compliant, pragmatic solutions
Project & Change Management
Experience managing multiple deadlines and priorities in a fast-paced environment
Familiarity with electronic quality and change management systems (e.g., eQRMS, Infinity, Verity/Veeva)
Ability to support planning and prioritization of team deliverables
Collaboration & Communication
Proven ability to work effectively in cross-functional global teams
Excellent written and verbal communication skills, with the ability to translate complex technical information for diverse audiences
Strong interpersonal skills and ability to influence without authority
Leadership & Growth
Demonstrated initiative and accountability, with appropriate level of independence
Ability to mentor junior staff and contribute to team development
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Preferred Qualifications
Experience with biologics and/or advanced therapies (cell & gene therapy)
Exposure to global regulatory interactions and agency communications
Experience supporting both clinical and commercial-stage products
