Regulatory Affairs Executive

Zuellig Pharma; Shah Alam; Presencial; MYR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Inclusive environment

Career growth

Total Rewards

Regional exposure

Descripción de la vacante

Zuellig Pharma Malaysia seeks a Regulatory Pharmacovigilance Associate to ensure safety reporting complies with NPRA and international PV guidelines. You will act as the liaison for pharmacovigilance matters with NPRA, clients, and healthcare professionals.

You will guide the Regulatory Affairs Team on regulatory changes, maintain ICSR timelines, and help prepare safety documentation to meet service levels. A pharmacy degree and familiarity with PV principles are required or preferred.

Formación

• Bachelor's degree in Pharmacy or equivalent and registered pharmacist preferred.
• Familiarity with pharmacovigilance principles and local PV regulations.
• Excellent written and verbal communication; strong documentation practices.

Responsabilidades

• Ensure safety reporting aligns with local NPRA and international PV guidelines.
• Liaise with NPRA, regulatory agencies, and clients on pharmacovigilance matters.
• Guide Regulatory Affairs Team on regulatory policy changes affecting PV.
• Support inspections, audits, and other duties as requested by Head of Regulatory.

Conocimientos

PV knowledge

Regulatory affairs

Documentation

Communication

Attention to detail

NPRA familiarity

Educación

Bachelor's degree in Pharmacy

Registered Pharmacist

Herramientas

Veeva Systems

MS Office

Descripción del empleo

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

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 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 escalat e 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

• 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

• 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.