GRA CMC Specialist
Core
Develop and execute global Chemistry, Manufacturing and Controls (CMC) regulatory strategies to support the development, registration, and lifecycle management of innovative biologic therapies.
Role type
Regulatory Scientist (CMC Specialist)
Builds
Global regulatory submissions (clinical trial applications, marketing applications, lifecycle variations) for biologic products
Domain
Biopharmaceuticals / Biologics
Required skills
CMC regulatory strategy, regulatory documentation preparation, cross-functional collaboration, regulatory impact assessment, inspection readiness support, global regulatory requirements interpretation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes; Coordinate the preparation, review, and maintenance of CMC regulatory documentation to support global submissions; Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle; Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact; Prepare and review regulatory content for submissions including marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions; Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities; Interpret evolving global regulatory requirements and assess their impact on products and development programs; Support inspection readiness activities and contribute to continuous improvement of regulatory processes
Seniority
Mid-level (3+ years experience)