Regulatory Compliance Officer

2 days ago


Karachi, Sindh, Pakistan Associated Talent Consultants Full time
Role Summary:

We are seeking a highly skilled Regulatory Compliance Officer to join our team at Associated Talent Consultants. The ideal candidate will have extensive experience in quality leadership, regulatory compliance, and international quality certifications.

Main Responsibilities:

  1. Regulatory Compliance: Develop and implement quality strategies aligned with international regulatory requirements to ensure compliance and continuous improvement.
  2. QA/QC Operations: Oversee and manage QA and QC operations, ensuring the highest standards of product quality and safety.
  3. Certification and Compliance: Ensure successful certification and compliance with international standards such as GMP, WHO, FDA, EU, and SFDA (Saudi Food & Drug Authority).
  4. Audits and Inspections: Lead internal and external regulatory audits and inspections, addressing any non-compliance issues effectively.
  5. Quality Control: Monitor quality control processes across all manufacturing operations, ensuring adherence to validated procedures.
  6. Risk Management: Implement risk management and quality improvement initiatives to enhance product reliability and reduce defects.
  7. Team Leadership: Provide strategic leadership and training to the quality team, fostering a culture of continuous improvement.
  8. Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure smooth product development and compliance.
  9. Trend Monitoring: Stay updated on global quality trends and regulatory changes, advising management on necessary adjustments.

Requirements:

  • 15+ years of experience in Quality Assurance and Quality Control, with at least 5 years in a leadership role.
  • In-depth knowledge of pharmaceutical manufacturing regulations, particularly in GCC markets.
  • Strong experience in international quality certifications and compliance (GMP, WHO, FDA, EU, SFDA).
  • Proven track record in managing audits, regulatory inspections, and implementing CAPA (Corrective and Preventive Actions).
  • Ability to lead and mentor cross-functional teams to drive quality excellence.
  • Strong analytical, problem-solving, and decision-making skills.

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