Regulatory Affairs Specialist I — Global Med Devices

Alcon MX

Selangor

On-site

MYR 60,000 - 90,000

Full time

2 days ago

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Job summary

ALCON in Malaysia (Selangor) is seeking a Regulatory Affairs Specialist to support Product Lifecycle Management and regulatory maintenance, ensuring timely registrations and compliant lifecycle changes. You will drive registrations, manage labeling changes, prepare CPDS, review promotional materials, and provide regulatory support to local teams in an international environment.

The role requires a degree in engineering/pharmacy/science, fluent English, 1–2 years of experience (fresh grads

Qualifications

Degree in Engineering, Pharmacy, Science or related field.
Fluent in English (spoken and written).
1–2 years of regulatory affairs experience; fresh graduates welcome.
Strong interpersonal and communication skills.
Ability to work independently in an international environment.

Responsibilities

Regulatory Affairs drive product registration, re-registration, change notification and related license applications & maintenance.
Drive product lifecycle management activities (labeling changes, new regulations assessment and preparation, CPDS, promotional material reviews).
Manage administrative and coordination activities (project tracking, archival of licenses / permits, invoice & payment tracking).
Provide regulatory support to local teams.
Newcomer onboarding and other duties as assigned.