M&S-China EM&S Quality Regulatory Manager-Shanghai
Core
Establish and maintain Quality Management Systems for contract manufacturing, manage local product regulatory compliance, and supervise production processes to ensure adherence to GMP and regulatory requirements.
Role type
Senior Quality Regulatory Manager (Pharmaceuticals)
Builds
Quality Management Systems, regulatory filings, and compliant production processes for biological products.
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
GMP regulations, ICH guidelines, MAH system operations, sterile drug production, change control, supplier management, risk assessment, CAPA management, regulatory inspections, quality metrics, SOP development, training management, artwork review, pharmacopoeia changes.
Preferred skills
MAH system operations experience, English proficiency.
Technologies
N/A
Responsibilities
Establish and maintain Quality Management Systems (B Certificate) for contract manufacturing; Liaise with health authorities for product permissions, GMP, and tender certificates; Manage change control systems and post-marketing changes; Maintain regulatory databases and prepare SOPs; Review and approve packing material artworks; Manage supplier evaluation and quality agreements; Perform on-site supervision of contract manufacturing processes; Coordinate regulatory inspections and audits.
Seniority
Senior, hands-on IC
