Regulatory Support Specialist (f/d/m)
Core
Provide regulatory support to Product Managers, regions, and customers by delivering quality documents and technical information for bioprocess products.
Role type
Regulatory Support Specialist
Builds
Regulatory support documentation, statements, and certificates for bioprocess products
Domain
Life sciences / Biotechnology / Bioprocess
Required skills
GMP knowledge, regulatory requirements understanding, document development, database management, certificate preparation, NDA review, portal access management
Preferred skills
Large matrix organization experience, local language fluency, customer communication
Technologies
Internal and external regulatory databases, customer portals
Responsibilities
Build and maintain knowledge of customer regulatory requirements; Develop and update regulatory support documentation; Perform investigations and prepare/deliver statements and certificates; Respond to customer regulatory issues; File and maintain documentation in databases; Approve customer portal accesses; Review and approve NDAs
Seniority
Mid-level, hands-on IC
