Senior Manager Global Regulatory Affairs CMC
Core
Lead global regulatory CMC strategy for biological and non-biological product portfolios, managing submissions and compliance with regulatory agencies.
Role type
Senior Manager, Global Regulatory Affairs CMC
Builds
Regulatory submissions (new marketing applications, clinical trial applications, variations, periodic reports) and lifecycle management for biologics and non-biological products.
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Global CMC regulations, regulatory submission authoring, change control assessment, cross-functional team leadership, strategic planning, stakeholder negotiation, SOP development, outsourcing management
Preferred skills
Advanced degree (MS, PhD), biologics or plasma industry experience, mentoring diverse teams
Technologies
Quality management systems, regulatory submission platforms
Responsibilities
Define global regulatory strategies for product development and registration; Manage development and submission of CMC regulatory documents; Lead change control assessments for product-related changes; Represent the company as an authorized official with regulatory agencies; Develop and implement regulatory policies and procedures; Provide regulatory consultation to R&D and Operations; Support outsourcing of regulatory activities.
Seniority
Senior Manager, strategic leadership & cross-functional collaboration