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CMC Regulatory Affairs Specialist

2 months ago

Boston, Massachusetts, United States Ismile Technologies Full time
Job Title: CMC Expert - Biologics

Location: Hybrid (NJ, Boston)

Job Description:

We are seeking a highly skilled 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.

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