Regulatory Affairs Manager

A leading pharmaceutical organisation in Petaling Jaya is seeking a Regulatory Affairs Manager & Responsible Pharmacist for a full-time, permanent role. You will lead regulatory strategy, ensure compliance with Malaysian pharmaceutical regulations, and oversee product registration and lifecycle management. This is an excellent opportunity to contribute to new product launches and drive regulatory excellence within a growing pharmaceutical organisation.

What you'll do:

As a Regulatory Affairs Manager and Responsible Pharmacist based in Petaling Jaya, you will play a crucial role in shaping regulatory strategy for pharmaceutical products. Your day-to-day responsibilities will involve developing robust strategies for product registration and market access while collaborating with both local teams and global headquarters. You will oversee submission processes for new drug applications—including variations and renewals—ensuring all documentation meets stringent NPRA requirements. Engaging proactively with stakeholders such as NPRA officials and Pharmacy Board representatives will be essential in facilitating smooth market entry. You will also act as the Responsible Pharmacist (RP), holding Poison Licences on behalf of the organisation while ensuring strict adherence to legal frameworks like the Poison Act. Your oversight of Good Distribution Practice (GDP) will ensure proper storage conditions and traceability of controlled substances. Additionally, you will manage licensing renewals and maintain accurate records for all regulated medicines. Training internal departments on GDP standards and pharmacovigilance updates forms part of your remit alongside coordinating product recalls or adverse event reporting when necessary. Success in this role requires exceptional organisational skills combined with a deep understanding of Malaysian pharmaceutical regulations.

• Develop and implement comprehensive regulatory strategies to support timely product registration, launch, and market access in Malaysia.
• Collaborate closely with Head Office Regulatory Affairs teams to align local plans with global corporate objectives for seamless execution.
• Engage proactively with stakeholders including NPRA, Pharmacy Board of Malaysia, MOH, and other relevant authorities to facilitate accelerated market entry and regulatory intelligence gathering.
• Lead end-to-end submissions for new drug applications, variations, renewals, labelling updates, and post-approval changes while overseeing preparation of ASEAN CTD dossiers and managing e-Submission platforms.
• Ensure all submissions meet NPRA requirements for biologics, generics, or combination products through meticulous attention to detail and accuracy.
• Maintain continuous inspection readiness by supporting NPRA audits, internal audits, distributor evaluations, addressing deficiencies promptly, and implementing corrective actions.
• Build strong relationships with regulatory bodies by acting as company spokesperson during meetings, site visits, audits, and maintaining up-to-date regulatory files in compliance with SOPs.
• Act as the appointed Responsible Pharmacist (RP) holding Poison Licences on behalf of the company while ensuring legal compliance with the Poison Act and related regulations.
• Monitor Good Distribution Practice (GDP) across storage, transportation, product handling activities; supervise temperature logs and controlled drugs documentation for inventory traceability.
• Manage renewal of pharmacy licenses as well as import, wholesale, product licenses; maintain poison book records and controlled medicine documentation according to legal requirements.

What you bring:

The ideal candidate for the Regulatory Affairs Manager and Responsible Pharmacist position brings proven experience from the pharmaceutical sector—particularly within regulatory affairs—and holds credentials as a Registered Pharmacist under Malaysian law. Your background includes hands-on involvement in submission management for drug registrations along with familiarity navigating NPRA guidelines or ASEAN harmonisation protocols. You possess strong interpersonal skills enabling effective stakeholder engagement whether communicating complex requirements or negotiating outcomes during audits. Leadership comes naturally to you; you thrive when guiding cross-functional teams through challenging projects while maintaining meticulous records that satisfy both local standards and global SOPs. Your ability to assess risk judiciously ensures compliance even amidst evolving regulations. Proficiency using digital tools like MS Office or eCTD platforms streamlines your workflow while your commitment to ongoing learning supports continual improvement across departments. By sharing your expertise through training sessions or collaborative initiatives you contribute positively to organisational goals.

• Bachelor’s Degree in Pharmacy (BPharm) from a recognised university is required for eligibility.
• Registered Pharmacist status with the Pharmacy Board of Malaysia along with a valid Annual Retention Certificate (ARC) is mandatory.
• 5–8 years’ experience in Regulatory Affairs within the pharmaceutical industry is highly preferred; additional MedTech experience is advantageous.
• Proven track record as a Responsible Pharmacist or demonstrated experience in regulatory-compliance roles is essential for success.
• Comprehensive knowledge of Malaysian regulatory frameworks including NPRA guidelines and ASEAN harmonisation standards is expected.
• Excellent communication skills coupled with negotiation abilities when dealing with regulatory authorities or internal/external stakeholders are vital.
• Leadership qualities combined with project management capabilities enable effective cross-functional collaboration within multicultural environments.
• Meticulous attention to detail ensures high standards for accuracy in submissions while maintaining compliance across all operations.
• Sound judgement in managing regulatory risks supported by proficiency in MS Office tools plus familiarity with submission systems such as NPRA QUEST or eCTD tools enhances efficiency.
• Ability to work dependably both independently and collaboratively within diverse teams fosters communal achievement.

What sets this company apart:

This organisation stands out as one of Malaysia’s most respected names in pharmaceuticals—offering employees not only competitive remuneration but also genuine opportunities for professional development within an inclusive environment. Flexible working arrangements allow you to balance personal commitments alongside career ambitions while generous car allowances reflect appreciation for your contributions. The leadership team is committed to nurturing talent through regular training sessions focused on GDP standards or pharmacovigilance updates so you can stay ahead of industry trends. Collaboration across departments is encouraged fostering communal achievement rather than individual competition; every voice matters here regardless of background or experience level. With exposure to both local operations and global best practices you gain valuable insights that enhance your skillset further positioning yourself as an expert within regulatory affairs. The organisation’s dedication to compliance ensures stability even amidst changing regulations making it an ideal place for those who value dependability honesty empathy—and want their work to have lasting impact on public health outcomes.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C