Regulatory Compliance Professional

1 week ago

Singapore beBeeRegulatory Full time $120,000 - $180,000
Job Title:

Regulatory Compliance Officer

">Job Description:

A pivotal opportunity has arisen for an experienced regulatory professional to oversee product compliance and drive quality improvement initiatives within a dynamic global organization.

This critical role is responsible for ensuring products delivered meet stringent legal and customer requirements, driving quality enhancement programs, and monitoring GMP & QA activities for regulatory adherence.

  • Compliance Management: Ensure products conform to regulatory standards. Drive quality enhancement programs and activities. Address process quality issues and customer inquiries.
  • Monitor GMP & QA Activities: Monitor GMP & QA activities of the organization for regulatory compliance.
  • Interpret & Comply with Quality Standards: Interpret and comply with quality assurance regulations.
  • Support Day-to-Day Quality Activities: Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies.
  • Regulatory Oversight: Oversee implementation and ensure efficiency of inspection and quality systems.
  • Document Quality Activities: Document quality assurance activities such as internal audits.
  • Analyze Customer Grievances: Analyze customer grievances and other non-compliance issues.
  • Providing Training: Provide training for employees to ensure compliance with SOPs.
  • Analyze Audit Outcomes: Analyze audit outcomes and carry out corrective procedures.
  • Maintain Pharmaceutical & Medical Device Quality System: Establish and maintain pharmaceutical and medical device quality system in accordance with the organization's quality policy.
  • Evaluate Quality Management Systems: Evaluate established Quality Management System such as Product Complaint & Recall, Internal & External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management.
Responsibilities:
  • Develop strategic registration strategies for products/projects.
  • Provide regulatory guidance for global teams.
  • Act as primary point of contact to relevant authorities/external organizations for products/projects.
  • COORDINATE OR MONITOR REGULATORY SUBMISSIONS.

Applicants should possess at least 7 years' experience in RA/QA roles and hold a relevant science degree. Please submit your updated CV.

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