Head of Regulatory Affairs

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><div><p><b>About Abbott</b></p><p>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.</p><p></p><p>At Abbott, you can do work that matters, grow your career, care for yourself and your family, and live a full life with:</p><ul><li><p>Global career development opportunities</p></li><li><p>A workplace recognized as a &#34;Great Place to Work&#34; across multiple countries</p></li><li><p>A culture that supports diversity, inclusion, and work–life integration</p></li><li><p>Market‑competitive benefits and career pathways</p></li></ul><p></p><p><b>The Opportunity</b></p><p>This role is based in <b>Petaling Jaya</b>, within our <b>Established Pharmaceuticals Division (EPD)</b>. You will lead all <b>Regulatory Affairs (RA)</b> and <b>Quality Assurance (QA)</b> activities for <b>Malaysia and Brunei</b>, ensuring compliance with national and regional regulations, and supporting the business through strategic regulatory and quality leadership.</p><p></p><p>You will play a critical role in shaping regulatory strategy, ensuring operational excellence, and partnering with health authorities, industry bodies, and internal stakeholders.</p><p></p><p><b>What You’ll Do</b></p><p><b>Regulatory Strategy &amp; Leadership</b></p><ul><li><p>Develop and execute regulatory strategies aligned with business goals for Malaysia and Brunei.</p></li><li><p>Serve as the primary liaison with health authorities (MOH, DCA, MDA, PHAMA, enforcement bodies).</p></li><li><p>Lead regulatory planning for new product launches, lifecycle management, biosimilar portfolios, and regional submissions.</p></li><li><p>Act as Subject Matter Expert (SME) and country expert on all RA matters.</p></li><li><p>Represent Abbott in regulatory forums and industry groups to influence evolving regulatory landscapes.</p></li><li><p>Provide regulatory insights to cross‑functional teams and senior leadership.</p></li></ul><p></p><p><b>Regulatory Operations</b></p><ul><li><p>Oversee product registration dossiers, variations, renewals, PSURs, and clinical trial applications.</p></li><li><p>Ensure compliance for pharmaceuticals, OTC, supplements, traditional products, medical devices, and cosmetics.</p></li><li><p>Monitor and assess regulatory changes; provide regulatory intelligence updates.</p></li><li><p>Ensure alignment with ASEAN, ICH, WHO standards.</p></li><li><p>Lead regulatory risk management including audits, inspections, and recall readiness.</p></li><li><p>Drive halal certification strategy and regulatory readiness for vaccine lot releases.</p></li></ul><p></p><p><b>Quality Assurance</b></p><ul><li><p>Lead and maintain the Quality Management System (QMS) ensuring compliance with GMP, GDP, NPRA, and Abbott global quality standards.</p></li><li><p>Oversee product quality reviews, deviations, CAPA, change control, and complaint handling.</p></li><li><p>Lead internal/external audits and regulatory inspections.</p></li><li><p>Partner with RA, Supply Chain, and Commercial teams to ensure QA alignment for launches and market activities.</p></li><li><p>Build a culture of quality through continuous improvement, training, and governance.</p></li></ul><p></p><p><b>Cross‑Functional Collaboration</b></p><ul><li><p>Work closely with Commercial, Medical, Supply Chain, and Quality teams.</p></li><li><p>Provide regulatory and QA guidance for promotional materials, labeling, packaging, and market activities.</p></li><li><p>Support internal stakeholders on ad‑hoc RA/QA topics.</p></li></ul><p></p><p><b>Required Qualifications</b></p><ul><li><p>Bachelor’s Degree in <b>Pharmacy</b>, <b>Life Sciences</b>, or <b>Science</b>.</p></li><li><p>Minimum <b>10 years’ experience</b> in Regulatory Affairs and/or Quality Assurance within the pharmaceutical or healthcare sector.</p></li><li><p>Strong experience interfacing with regulatory agencies and leading regulatory/quality strategies.</p></li><li><p>Proven leadership, project management, and problem‑solving capabilities.</p></li><li><p>Excellent communication, negotiation, and stakeholder management skills.</p></li></ul><p></p><p><b>Preferred Skills</b></p><ul><li><p>Deep understanding of Malaysia &amp; Brunei health authority processes.</p></li><li><p>Experience working with regional or cluster‑level submissions.</p></li><li><p>Strong analytical and compliance‑driven mindset.</p></li><li><p>Ability to influence, collaborate, and lead cross‑functional initiatives.</p></li></ul></div><p></p><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Regulatory Operations<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>EPD Established Pharma<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>Malaysia &gt; Selangor : Imazium, No. 8, Jalan SS 21/37<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>