We are currently looking for a Regulatory Affairs Manager/Assistant Manager to join a pharmaceutical manufacturing giant in the industry with a legacy of over 60 years globally. You will take on a strategic leadership role in a diverse product portfolio spanning pharmaceuticals, medical devices, and cosmetics. You will influence global regulatory strategies, collaborate across departments, and ensure compliance for impactful decisions that enhance public health and safety. This role requires your urgent attention.
- Reporting to: Deputy GM
- Location: Kuala Lumpur
- Excellent compensation package and benefits
- Offers great flexibility and hybrid working style
the role
- Document Review and Compliance: Thoroughly review and endorse technical documents for accuracy before submitting to regulatory bodies, ensuring compliance with specific submission requirements across pharmaceuticals, medical devices, and cosmetics.
- Registration Strategy Implementation: Execute plans for product registrations in established and new markets, ensuring timely acquisition of approvals.
- Technical Document Evaluation: Lead the assessment of technical documents and facilitate precise responses to regulatory authorities for new products and modifications.
- Regulatory Guidance: Provide regulatory advice to internal and external stakeholders on product registration matters, sustaining licenses, and interpreting regulatory requirements.
- Change Management and Oversight: Manage transitions in registered details smoothly, approve promotional materials, and ensure compliance with post-market surveillance and clinical study obligations.
- Serve as the primary point of contact with regulatory authorities and strategic partners (contract manufacturers, in-licensing, and out-licensing partners) for matters related to product registration, pharmacovigilance, and clinical studies.
the experience
- Bachelor’s degree in a science-related field, accompanied by a proven track record of at least 3 years in regulatory affairs within pharmaceutical/healthcare companies or regulatory agencies.
- Relevant experience in direct interactions with regulatory authorities.
- Exhibits a high degree of precision, keen attention to detail, and strong interpersonal aptitude.
- Proficient in written and spoken English and Bahasa Malaysia
how to apply
To apply online, please click on the appropriate link. Alternatively, please contact Shash at 0129175705 or drop an email to shash.prasanan@randstad.com.my if you are interested in the job.
Randstad Malaysia
Level 3A Menara BT, Tower 3 Avenue 7 The Horizon,
No 8 Jalan Kerinchi, 59200 Kuala Lumpur
M +6012 917 5705
shash.prasanan@randstad.com.my
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