Global Regulatory Affairs Specialist

Merck; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Job summary

Merck is seeking a Regulatory Affairs professional to support timely preparation, submission, and follow-up of new Marketing Authorization applications to local authorities, under the supervision of the Associate Director.

The role also covers maintenance activities for assigned products, including variations, renewals, and supplementary approvals, with a focus on ensuring compliant labeling translation, artwork management, and ongoing regulatory liaison to health authorities.

Job description

Merck is seeking a Regulatory Affairs professional to support timely preparation, submission, and follow-up of new Marketing Authorization applications to local authorities, under the supervision of the Associate Director.

The role also covers maintenance activities for assigned products, including variations, renewals, and supplementary approvals, with a focus on ensuring compliant labeling translation, artwork management, and ongoing regulatory liaison to health authorities.