International CMC RA Director

Domnic Lewis is mandated to hire forInternational CMC RA Director for Bangalore location.

Introduction:

Key Responsibilities:

• Provide comprehensive CMC regulatory guidance across all business functions.
• Lead strategic initiatives aimed at enhancing operational efficiency and regulatory compliance.
• Offer strategic, operational, and tactical direction for CMC submissions throughout the product lifecycle.
• Manage high-level risks through informed decision-making, innovative problem-solving, and proactive risk management strategies.

Essential Skills and Experience:

• A degree or PhD in a scientific or technical discipline (e.g., pharmacy, biology, chemistry).
• Extensive knowledge of manufacturing, technical project management, and regulatory affairs.
• Deep understanding of global regulatory requirements.
• Direct experience in Regulatory Affairs CMC, particularly with submissions for synthetic and/or biologic products.
• Strong capabilities in stakeholder and project management.
• Proficiency in regulatory frameworks, especially those governing biotechnology products such as monoclonal antibodies.
• Experience with regulatory health authority interactions, inspections, and advocacy efforts.
• Post-graduate qualifications are preferred.
• Business acumen and an understanding of financial and supply chain dynamics.

Work Environment: