Global Regulatory Affairs CMC lead

Role Summary

Global Regulatory Affairs CMC lead responsible for developing and implementing global regulatory CMC strategies for development and marketed products, primarily for biological entities and vaccines, and serving as the primary regulatory liaison with health authorities. This role involves leading cross-functional collaboration to ensure compliance and timely approvals throughout 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

• BS/BA degree in a relevant scientific discipline required with at least 2-5 years regulatory experience.
• Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.
• Knowledge of FDA regulations is essential.
• Experience with biological and/or small molecule products

Skills

• Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
• Excellent organizational/planning and communication (written and verbal) skills.
• Demonstrated ability to work successfully on project teams.
• Experience or interest on using IA to produce information or data intended to support CMC filings
• RAC certification preferred
• Previous experience working in a fast paced environment on multiple product lines