Senior Manager Regulatory CMC

Key Responsibilities

• Lead regulatory CMC activities associated with post-approval changes, lifecycle management, and global maintenance submissions.
• Develop and execute regulatory strategies for manufacturing changes, process improvements, facility updates, and other CMC-related initiatives.
• Assess proposed changes for regulatory impact and determine appropriate filing strategies across global markets.
• Prepare, review, and coordinate CMC documentation for regulatory submissions, including variations, supplements, amendments, annual reports, and other lifecycle management activities.
• Partner with technical operations, quality, manufacturing, supply chain, and external partners to support global regulatory objectives.
• Provide regulatory guidance to cross-functional teams regarding applicable regulations, guidelines, and submission requirements.
• Monitor evolving global regulatory requirements and assess potential impact on products and ongoing development programs.
• Participate in change control and governance forums to ensure appropriate regulatory assessment of proposed changes.
• Support health authority interactions and contribute to regulatory responses, inspections, and information requests as needed.
• Drive continuous improvement initiatives to enhance regulatory processes, tools, and operational efficiency.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Minimum of 8 years of experience within the pharmaceutical, biotechnology, medical device, or related life sciences industry.
• At least 5 years of direct Regulatory CMC experience supporting product development and/or commercial products.
• Experience preparing and supporting global CMC submissions and lifecycle management activities.
• Strong knowledge of international regulatory requirements and guidelines governing CMC submissions and post-approval changes.
• Familiarity with regulatory information management systems and electronic document management platforms.
• Understanding of pharmaceutical development, manufacturing processes, quality systems, and regulatory compliance principles.
• Demonstrated ability to develop and communicate regulatory strategies across multidisciplinary teams.
• Experience evaluating complex regulatory issues and providing practical, risk-based recommendations.
• Strong organizational, communication, and project management skills with the ability to work independently in a fast-paced environment.