Regulatory Affairs jobs in Malaysia
Regulatory Affairs Manager (Malaysia)
Macleods Pharmaceuticals Sdn Bhd
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Clinical Research Associate
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Dexcom Deutschland GmbH
Regulatory Affairs Manager (Malaysia)
Job summary
A global pharmaceutical company is seeking a Regulatory Affairs Manager in Kuala Lumpur, Malaysia. This high-impact leadership role involves overseeing regulatory affairs activities, managing NPRA submissions, and developing strategies for product launches. The ideal candidate will possess a Bachelor’s or Master’s degree in a relevant field, a minimum of 5–8 years of regulatory experience, and a proven track record in obtaining NPRA approvals. Join us to lead a growing team and advance your career in an international setting.
Benefits
Qualifications
- 5–8 years of regulatory affairs experience in Malaysia.
- Proven track record of NPRA submissions and approvals.
- Strong leadership and decision-making abilities.
Responsibilities
- Lead all regulatory affairs activities for Malaysia.
- Develop regulatory strategies for new product launches.
- Manage NPRA submissions and regulatory compliance.
Skills
Education
Macleods Pharmaceutical Sdn Bhd | Full-Time | Immediate Hiring
Macleods Pharmaceutical Sdn Bhd is a global pharmaceutical company expanding its footprint in Malaysia. We are seeking a Regulatory Affairs Manager to lead and oversee all regulatory affairs activities, ensuring timely approvals and compliance with NPRA and Malaysian regulatory requirements.
This is a high-impact leadership role ideal for a candidate with strong NPRA experience and a proven track record in regulatory strategy and submissions.
- Lead and oversee all regulatory affairs activities for Malaysia
- Develop regulatory strategies for new product launches and portfolio expansion
- Manage complex NPRA submissions, variations, renewals, and post-marketing commitments
- Serve as the key contact with NPRA, MOH, and auditors
- Review and approve regulatory sections of labels, inserts, and marketing materials
- Advise management on regulatory risks and compliance matters
- Mentor and guide RA team members
- Ensure regulatory documentation and processes are accurate, timely, and compliant
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- Minimum 5–8 years regulatory affairs experience in Malaysia
- Proven track record of NPRA approvals
- Strong leadership, project management, and stakeholder management skills
- Detail-oriented, proactive, and able to make strategic decisions
- Excellent communication skills in English/Malay (both written and verbal)
- Lead regulatory affairs for a growing international pharmaceutical company
- Exposure to high-impact projects and product launches
- Competitive salary plus benefits
- Opportunity to mentor and grow your regulatory team
- Dynamic work environment with career progression opportunities
to join Macleods Pharmaceutical and play a key role in shaping regulatory strategies and ensuring compliance in Malaysia!
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.