JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science that improves people’s health at all stages of life. We are committed to delivering innovative, trusted solutions across diagnostics, medical devices, nutrition, and pharmaceuticals.

At Abbott, you can do work that matters, grow your career, care for yourself and your family, and live a full life with:

• Global career development opportunities

• A workplace recognized as a "Great Place to Work" across multiple countries

• A culture that supports diversity, inclusion, and work–life integration

• Market‑competitive benefits and career pathways

The Opportunity

This role is based in Petaling Jaya, within our Established Pharmaceuticals Division (EPD). You will lead all **Regulatory Affairs (RA)**and **Quality Assurance (QA)**activities for Malaysia and Brunei, ensuring compliance with national and regional regulations, and supporting the business through strategic regulatory and quality leadership.

You will play a critical role in shaping regulatory strategy, ensuring operational excellence, and partnering with health authorities, industry bodies, and internal stakeholders.

What You’ll Do Regulatory Strategy & Leadership

• Develop and execute regulatory strategies aligned with business goals for Malaysia and Brunei.

• Serve as the primary liaison with health authorities (MOH, DCA, MDA, PHAMA, enforcement bodies).

• Lead regulatory planning for new product launches, lifecycle management, biosimilar portfolios, and regional submissions.

• Act as Subject Matter Expert (SME) and country expert on all RA matters.

• Represent Abbott in regulatory forums and industry groups to influence evolving regulatory landscapes.

• Provide regulatory insights to cross‑functional teams and senior leadership.

Regulatory Operations

• Oversee product registration dossiers, variations, renewals, PSURs, and clinical trial applications.

• Ensure compliance for pharmaceuticals, OTC, supplements, traditional products, medical devices, and cosmetics.

• Monitor and assess regulatory changes; provide regulatory intelligence updates.

• Ensure alignment with ASEAN, ICH, WHO standards.

• Lead regulatory risk management including audits, inspections, and recall readiness.

• Drive halal certification strategy and regulatory readiness for vaccine lot releases.

Quality Assurance

• Lead and maintain the Quality Management System (QMS) ensuring compliance with GMP, GDP, NPRA, and Abbott global quality standards.

• Oversee product quality reviews, deviations, CAPA, change control, and complaint handling.

• Lead internal/external audits and regulatory inspections.

• Partner with RA, Supply Chain, and Commercial teams to ensure QA alignment for launches and market activities.

• Build a culture of quality through continuous improvement, training, and governance.

Cross‑Functional Collaboration

• Work closely with Commercial, Medical, Supply Chain, and Quality teams.

• Provide regulatory and QA guidance for promotional materials, labeling, packaging, and market activities.

• Support internal stakeholders on ad‑hoc RA/QA topics.

Required Qualifications

• Bachelor’s Degree in Pharmacy,Life Sciences, or Science.

• Minimum 10 years’ experience in Regulatory Affairs and/or Quality Assurance within the pharmaceutical or healthcare sector.

• Strong experience interfacing with regulatory agencies and leading regulatory/quality strategies.

• Proven leadership, project management, and problem‑solving capabilities.

• Excellent communication, negotiation, and stakeholder management skills.

Preferred Skills

• Deep understanding of Malaysia & Brunei health authority processes.

• Experience working with regional or cluster‑level submissions.

• Strong analytical and compliance‑driven mindset.

• Ability to influence, collaborate, and lead cross‑functional initiatives.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma:

LOCATION:

Malaysia > Selangor : Imazium, No. 8, Jalan SS 21/37

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable