Job Title: CMC Regulatory Affairs - Operations Specialist
Location: Giralda Farms, NJ (Hybrid)
Duration: 6-12 Months
Position Summary:
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.
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
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
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
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