Senior Manager Regulatory CMC

Senior Manager, Regulatory CMC

The Senior Manager, Regulatory CMC is responsible for supporting global regulatory chemistry, manufacturing, and controls (CMC) activities with an emphasis on lifecycle management, post-approval changes, and regulatory compliance. This role partners closely with cross-functional teams to develop and execute regulatory strategies that support both commercial products and development-stage programs across a range of product modalities.

The successful candidate will have a strong understanding of global regulatory requirements, post-approval change management, and CMC regulatory strategy. This individual will contribute to regulatory submissions, provide strategic guidance to development and manufacturing teams, and support the maintenance of regulatory compliance throughout the product lifecycle.

This company is pioneering RNA interference-based therapeutics to address serious diseases with high unmet medical need. Its innovative platform enables targeted delivery to specific tissues, allowing for precise gene silencing and durable therapeutic effects.

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.