Senior Consultant, Regulatory Affairs & Remediation (Mandarin)

Remediation Consultant Ex-FDA Expert

Position Title & Basic Details
Were looking for a Remediation Consultant Ex-FDA Expert based in China. This is a contract position requiring 10-15 years of relevant experience. A Bachelors degree in a related field is strongly preferred.

Overview
In this role, you'll be responsible for leading the remediation process following a completed GAP assessment. The ideal candidate brings a solid foundation in regulatory compliance and thrives in a collaborative environment.

Key Responsibilities
- Lead the remediation process to address compliance deficiencies.
- Develop and implement Corrective and Preventive Actions (CAPA).
- Ensure alignment with FDA, EMA, NMPA, and other regulatory agencies expectations.
- Oversee quality system improvements, including documentation, SOPs, and operational workflows.
- Assist with audit preparation and response efforts, ensuring all remediation actions meet compliance standards.
- Provide on-site coaching and training to staff on GMP compliance and regulatory expectations.
- Monitor, track, and report progress on remediation activities to stakeholders.

Requirements
Education: Bachelors degree in a related field or equivalent experience.
Technical Expertise: Expert-level knowledge of cGMP regulations; familiarity with FDA 483s, Warning Letters, CAPAs, and regulatory enforcement actions is a plus.
Experience: Minimum 10-15 years working in regulatory compliance and remediation.
Soft Skills: Excellent communication, collaboration, and problem-solving abilities.

Preferred Qualifications
- Experience in sterile manufacturing, aseptic processing, or laboratory controls.
- Knowledge of facility design, validation, and regulatory submissions.
- Strong leadership and change management skills to drive compliance improvements.