Regulatory and Quality Manager
Core
Ensure end-to-end regulatory compliance across the product lifecycle and act as a key interface between regulatory requirements and business operations.
Role type
Regulatory and Quality Manager
Builds
Product licenses, certifications, regulatory filings, and market access documentation
Domain
Pharmaceutical industry
Deliverable
client delivery
Required skills
Regulatory planning, new product registrations, lifecycle maintenance, inspection readiness, regulatory change monitoring, GDP-compliant processes, pricing and reimbursement submissions, material review
Preferred skills
Quality systems, supply chain, pricing frameworks
Technologies
Global regulatory systems
Responsibilities
Lead regulatory planning, manage new product registrations and renewals, ensure compliance of product licenses, manage regulatory inspections, monitor regulatory changes, ensure compliance with local requirements for quality and distribution, review promotional materials
Seniority
Senior, hands-on IC
