Global Regulatory Affairs Specialist

MSD; Petaling Jaya; Vor Ort; MYR 70.000 - 110.000; Vollzeit

Zusammenfassung

MSD Malaysia is seeking a Regulatory Affairs professional to manage MA applications, variations, and labeling artwork under supervision. You will liaise with local authorities and internal teams to ensure timely approvals and lifecycle management.

The role requires a Bachelor's in Pharmacy or Life Science, strong communication and organizational skills, and proficiency with digital tools, including AI literacy. You will work with GRACS regions and QA/Medical Affairs to support compliance.

Qualifikationen

• 2+ years of experience in regulatory/medical/lab roles preferred.
• Bachelor's Degree in Pharmacy or Life Science required.
• Strong verbal and written communication, organization, and planning skills.
• Proficiency with digital workplace tools (word processing, spreadsheets, databases, collaboration tools) and AI literacy.

Aufgaben

• Prepare, submit and follow up MA applications with local authorities under supervision.
• Maintain licenses via variations and renewals with timely submissions.
• Translate and QA local PI/RiMUP and ensure accurate labeling components.
• Support regulatory interactions with health authorities for approvals and lifecycle management.
• Collaborate with QRP, Medical Affairs and PV to ensure compliance and quality.

Kenntnisse

Communication

Attention to detail

Organizational skills

Planning

Digital literacy

AI literacy

Teamwork

Ausbildung

Bachelor's Degree in Pharmacy or Life Science

Jobbeschreibung

MSD Malaysia is seeking a Regulatory Affairs professional to manage MA applications, variations, and labeling artwork under supervision. You will liaise with local authorities and internal teams to ensure timely approvals and lifecycle management.

The role requires a Bachelor's in Pharmacy or Life Science, strong communication and organizational skills, and proficiency with digital tools, including AI literacy. You will work with GRACS regions and QA/Medical Affairs to support compliance.