Global Regulatory Affairs CMC Lead

Role Summary

Global Regulatory Affairs CMC Lead responsible for driving global regulatory strategies for pharmaceutical and vaccine products, collaborating with cross-functional teams to navigate regulatory landscapes, optimize development and manufacturing processes, and influence drug approvals through negotiations with health authorities. Develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA across the product lifecycle.

Responsibilities

• Develop and implement global regulatory CMC strategies
• Create strategies for development and marketed products
• Focus on chemical entities, biological entities, and/or vaccine products
• Execute and adapt strategies as needed
• Serve as the primary point of contact for regulatory authorities
• Act as direct liaison with agencies like US FDA and EMA
• Develop positive relationships with regulators
• Support strategic negotiations with worldwide Regulatory Health Authorities
• Manage CMC documentation and submissions
• Write, prepare, review, and approve regulatory CMC dossiers
• Ensure dossiers meet quality standards
• Comply with regulatory requirements
• Maintain documentation accuracy and completeness
• Lead cross-functional collaboration
• Work closely with R&D Functions
• Collaborate with Manufacturing & Supply Functions
• Coordinate with GRA Regulatory Operations
• Ensure effective implementation of regulatory strategies
• Facilitate resolution of CMC issues
• Identify and manage regulatory risks
• Assess regulatory CMC opportunities and risks
• Develop risk mitigation strategies
• Communicate implications to project teams
• Articulate risk/benefit components to stakeholders
• Contribute to regulatory science and policy activities
• Monitor local and international Health Authority regulations and guidelines
• Participate in the review process for new regulations
• Anticipate potential regulatory paradigm shifts
• Track and communicate current Health Authority thinking and trends

Qualifications

• Experience: 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
• Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
• Communication: Strong written and verbal communication skills, with fluency in English
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth

Skills

• Regulatory strategy development
• CMC documentation and submissions
• Regulatory authority liaison (FDA, EMA)
• Cross-functional collaboration
• Risk assessment and mitigation
• Regulatory intelligence and trend analysis

Education

• Bachelor's degree in Chemistry, Biology, Pharmacy, or related field