Head Of Regulatory Affairs

Abbott

Petaling Jaya, Selangor, Malaysia
Base: n/a; bonus/equity: not specified; benefits: ...
Not specified (considering potential hybrid or onsite given the leadership nature of the role)
Lead regulatory strategy for malaysia and brunei
Oversee product registration dossiers and variations
Maintain quality management system compliance
Abbott is seeking a Head of Regulatory Affairs for its Established Pharmaceuticals Division in Petaling Jaya, Malaysia. The role involves leading regulatory and quality assurance activities, ensuring compliance with local and regional regulations, and collaborating with various stakeholders

Job Summary

  • This role leads all Regulatory Affairs and Quality Assurance activities for Malaysia and Brunei within the Established Pharmaceuticals Division.
  • The position requires serving as the primary liaison with health authorities including MOH, DCA, MDA, and PHAMA to ensure national compliance.
  • Abbott offers a culture supporting diversity, inclusion, and work-life integration alongside global career development opportunities.

Matching Summary

Match Score: 85

Abbott is seeking a Head of Regulatory Affairs for its Established Pharmaceuticals Division in Petaling Jaya, Malaysia. The role involves leading regulatory and quality assurance activities, ensuring compliance with local and regional regulations, and collaborating with various stakeholders.

Salary

Base: N/A; Bonus/Equity: Not specified; Benefits: Market-competitive benefits and career pathways

Skills & Requirements

Must-have

  • Lead regulatory strategy for Malaysia and Brunei
  • Oversee product registration dossiers and variations
  • Maintain Quality Management System compliance

Nice-to-have

  • Deep understanding of local health authority processes
  • Experience with regional cluster-level submissions
  • Strong analytical and compliance-driven mindset

Key Requirements

  • Bachelor's Degree in Pharmacy or Life Sciences
  • Minimum 10 years experience in Regulatory Affairs or QA
  • Proven leadership in pharmaceutical sector

Work Rights

Not specified

Tailored Resume

Cover Letter