CMC Regulatory Affairs Manager - Biologics

Job Title: CMC Expert - Biologics

Location: Hybrid (NJ, Boston)

Job Description

We are seeking a CMC Expert specializing in Biologics to provide regulatory and lifecycle management support for a large client. This role is instrumental in fulfilling client needs for regulatory submissions, ensuring compliance with post-approval processes, and managing lifecycle activities for Biologics products. The candidate will work in collaboration with global teams and stakeholders to maintain regulatory compliance, develop strategies, and provide expert advice on complex topics.

Key Responsibilities

• Develop and implement regulatory strategies based on scientific and industry trends for biologic products, ensuring compliance with EMA, FDA, ICH, WHO, and global regulations.
• Serve as the CMC Product Lead for assigned biologics, managing the delivery of regulatory milestones throughout the product lifecycle.
• Lead the development and execution of global regulatory strategies, assessing CMC changes, identifying global regulatory requirements, and evaluating supporting documentation.
• Author, review, and update CMC submission components (Module 1, 2.3, and 3) to support post-approval supplements, annual reports, registration renewals, and responses to health authority queries.
• Provide expert regulatory guidance for complex submissions, including MAA, major changes, and multiple bundled changes.
• Participate in cross-functional teams to address regulatory issues, assess technical information, and support change management activities.
• Lead client meetings, managing project governance and communicating regulatory risks and mitigation strategies to stakeholders.
• Support GMP submissions and regulatory assessments of CMC changes, ensuring alignment with regulatory standards and client change management systems.
• Provide leadership in product in-licensing, due diligence reviews, product divestment, and product withdrawals.
• Collaborate with internal teams, external partners, and stakeholders to ensure compliant execution of change management processes.
• Maintain job aids, trackers, and regulatory systems to support process management and project tracking.
• Demonstrate problem-solving abilities, manage multiple priorities, and respond flexibly to changing project needs and unexpected events.
  
  

Qualifications

• Proven track record of successful biologic product strategy development and execution through regulatory and scientific knowledge.
• In-depth understanding of global CMC regulatory requirements and ability to apply this expertise in a lifecycle management capacity.
• Experience in interpreting global regulations and ensuring CMC compliance for biologics.
• Effective communication skills, both written and verbal, with the ability to clearly articulate complex regulatory issues to stakeholders.
• Strong leadership skills with the ability to collaborate with cross-functional teams and manage client relationships.
• Technology-savvy, familiar with document management systems, change control management systems, and registration management systems.
  
  

Skills

• CMC Regulatory Expertise
• Global Product Strategy Development
• Post-Approval and Lifecycle Management
• Regulatory Submissions (Module 1, 2.3, 3)
• Change Management
• Risk Management and Mitigation
• Leadership and Stakeholder Communication
• GMP Submission Knowledge