Executive, Regulatory Affairs

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

Purpose of The Role:

Assist the Head of Regulatory in ensuring that safety reporting complies with Malaysia and International regulatory guidelines and Safety Data Exchange Agreements (SDEA) with Zuellig Pharma clients.

Be the contact person and liaison for Zuellig Pharma for Pharmacovigilance and Safety matters with NPRA, other relevant regulatory agencies and its clients. Guides Zuellig Pharma clients to prepare and ensure pharmacovigilance requirements are maintained, and service levels are met.

Provide guidance to the Regulatory Affairs Team and in terms of changes to regulatory and government policies related to Pharmacovigilance. Perform additional responsibilities under request of Head of Regulatory or Distribution Department as needed.  

What You’ll Do: (Maximum 10 points)

• Assist the Head of Regulatory in ensuring that safety reporting complies with Malaysia and International regulatory guidelines and Safety Data Exchange Agreements (SDEA) with Zuellig Pharma clients.

• Be the contact person and liaison for Zuellig Pharma for Pharmacovigilance and Safety matters with NPRA, other relevant regulatory agencies and its clients. Guides Zuellig Pharma clients to prepare and ensure pharmacovigilance requirements are maintained, and service levels are met.

• Provide guidance to the Regulatory Affairs Team and in terms of changes to regulatory and government policies related to Pharmacovigilance. Perform additional responsibilities under request of Head of Regulatory or Distribution Department as needed. 

• Receive, process, assess and report adverse events, product complaints and other safety information in accordance with local and global regulatory requirements.
• Ensure Individual Case Safety Reports (ICSRs) are complete, accurate and submitted within regulatory timelines.
• Perform follow-up activities to obtain complete and medically relevant safety information.
• Maintain accurate Pharmacovigilance documentation, databases and records.
• Support preparation of aggregate safety reports, risk management activities and other Pharmacovigilance deliverables.
• Ensure compliance with Pharmacovigilance SOPs, Global Pharmacovigilance Practices (GVP), ICH Guidelines and local Health Authority requirements.
• Support client onboarding, implementation of Pharmacovigilance agreements and operational activities.
• Participate in internal audits, client audits and Health Authority inspections, including CAPA implementation where required.
• Monitor Pharmacovigilance KPIs and identify opportunities to improve quality, compliance and operational efficiency.
• Collaborate effectively with Regulatory Affairs, Medical Affairs, Quality Assurance, Commercial teams and clients to ensure patient safety remains the highest priority.

What Will Make You Successful:

• Consistently meet regulatory reporting timelines.
• Produce accurate and high-quality safety case documentation.
• Demonstrate strong attention to detail with minimal quality findings.
• Identify potential patient safety risks early and escalate appropriately.
• Communicate effectively with clients, affiliates, Healthcare Professionals and Health Authorities.
• Maintain confidentiality and data integrity.
• Adapt quickly to evolving PV regulations.
• Support inspections and audits confidently.
• Continuously improve PV processes.
• Put patient safety at the centre of every decision.

Must-Have: (Maximum 4 points)

• Bachelor's Degree in Pharmacy (preferred), Medicine, Nursing, Biomedical Science, Life Sciences or equivalent.
• Registered Pharmacist (preferred but not mandatory).
• Basic understanding of Pharmacovigilance principles.
• Familiarity with local PV regulations (e.g. NPRA).
• Understanding of Individual Case Safety Reports (ICSRs).
• Knowledge of adverse event reporting timelines.
• Good documentation practices (GDocP/GVP).
• Excellent attention to detail.
• Strong written and verbal communication.
• Good organizational skills.
  • Microsoft Office proficiency.
  • Ability to work under strict timelines.

Advantage to Have: (Maximum 8 points)

• Experience with Veeva Safety or other PV databases.
• Experience handling:
  • Case processing
  • Literature screening
  • Aggregate reports (PSUR/PBRER/DSUR)
  • Signal detection
  • Risk Management Plans
• Local PV agreements
• Audit and inspection experience.
• Experience with Quality Management Systems (CAPA, Deviations, Change Control).

What We Offer:

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect.

#LI-JS2