International CMC RA Director

Job Description

International CMC RA Director Domnic Lewis is mandated to hire forInternational CMC RA Director for Bangalore location. Introduction: Join us as an International Director of CMC Regulatory Affairs, where you will play a pivotal role in providing strategic leadership and expertise across projects and diverse product portfolios from initial development through to global market launch and ongoing lifecycle management. This position offers a unique opportunity to shape international CMC strategies, identify and mitigate risks, and align preparations with the needs of global markets and patient requirements. Key Responsibilities: As International Director of CMC Regulatory Affairs, you will leverage your expertise to: 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: To excel in this role, you should possess: 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: We foster a collaborative environment that values diverse perspectives and encourages innovative thinking. While we prioritize in-office collaboration for at least three days a week to facilitate connectivity and agility, we also respect individual needs for flexibility.