Senior Regulatory Affairs Specialist – Drugs & Devices

Zvh; Kuala Lumpur; On-site; MYR 180,000 - 260,000; Full time

Job summary

Baxter is seeking an experienced Regulatory Affairs professional in Malaysia to lead local regulatory activities for drugs, biologics, and medical devices. You will oversee licensing, labeling, and submission of regulatory documents, ensuring timely compliance with local laws.

The role requires strong project management and regulatory strategy skills, with experience in licensing, variations, and renewals. Collaboration with cross-functional teams and timely responses to regulatory authorities

Qualifications

• At least 5 years of relevant regulatory experience in pharma, biologics or medical devices.
• Experience with registration, license extensions, variations and renewals in Malaysia.
• Ability to manage multiple regulatory projects and meet deadlines.

Responsibilities

• Lead local regulatory activities and strategies for licensing drugs, biologics and medical devices.
• Develop and execute regulatory project plans and identify key risks.
• Prepare, review and submit regulatory documents per local requirements.
• Maintain and update regulatory authorizations and labeling to comply with regulations.
• Provide regulatory guidance to project teams and escalate compliance risks as needed.

Education

Bachelor of Pharmacy

Pharmacist License

Tools

GDPMD knowledge

Job description

Baxter is seeking an experienced Regulatory Affairs professional in Malaysia to lead local regulatory activities for drugs, biologics, and medical devices. You will oversee licensing, labeling, and submission of regulatory documents, ensuring timely compliance with local laws.

The role requires strong project management and regulatory strategy skills, with experience in licensing, variations, and renewals. Collaboration with cross-functional teams and timely responses to regulatory authorities