Regulatory Affairs Specialist — MA Submissions & Lifecycle

MSD; Selangor; Vor Ort; MYR 60.000 - 120.000; Vollzeit

Zusammenfassung

MSD in Malaysia seeks a Regulatory Affairs professional to manage MA submissions, variations, and lifecycle activities under supervision. The role emphasizes labeling, artwork management, and regulatory intelligence to ensure swift approvals and compliance across markets.

You will collaborate with Medical Affairs, Quality, and PV teams while keeping up with local regulations. Strong communication and meticulous planning are essential for success in this fast-paced environment.

Qualifikationen

• Minimum 2 years' experience in the pharmaceutical industry, in regulatory, medical or lab roles.
• Bachelor's Degree in Pharmacy or Life Science or equivalent.
• Excellent verbal and written communication; strong organizational skills.
• Meticulous attention to detail; able to handle high workload and time pressure.
• Ability to work independently and in a team; proficient in digital tools.

Aufgaben

• Prepare and submit new Marketing Authorization (MA) applications to local authorities under supervision.
• Maintain licensed products through variations, renewals and post-approval actions.
• Translate and manage labeling, including PI/RiMUP and artwork with quality standards.
• Support regulatory interactions with health authorities for submissions and lifecycle management.
• Stay updated on local regulations and regulatory intelligence; inform relevant stakeholders.
• Maintain regulatory databases and archives; ensure SOPs are up to date.

Kenntnisse

Regulatory experience

Communication skills

Organizational skills

Attention to detail

Digital literacy

Ausbildung

Bachelor's Degree in Pharmacy or Life Science

Tools

MS Office

Jobbeschreibung

MSD in Malaysia seeks a Regulatory Affairs professional to manage MA submissions, variations, and lifecycle activities under supervision. The role emphasizes labeling, artwork management, and regulatory intelligence to ensure swift approvals and compliance across markets.

You will collaborate with Medical Affairs, Quality, and PV teams while keeping up with local regulations. Strong communication and meticulous planning are essential for success in this fast-paced environment.