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About the role
Key responsibilities & impact- Provide regulatory support to country and/or cluster regulatory teams across the product lifecycle
- Manage/support regulatory activities across assigned (Asia) markets and products
- Prepare and review local M1 dossier documents and submission-ready content
- Support simple health authority query responses and coordinate on more complex requests
- Review dossier build content for assigned submissions
- Support regulatory operational activities such as tenders, launch planning, APQR, audit readiness, and compliance support
- Escalate quality, compliance, or emerging risks where needed
Requirements
What you’ll need- Bachelor’s degree in Pharmacy or Life Sciences or equivalent relevant experience
- Experience in Regulatory Affairs within Malaysia or other
- Advanced to fluent English
- Strong technical aptitude and Microsoft Office skills
- Ability to work independently, solve problems, and manage ambiguity
- Experience in pharmaceutical regulatory, quality, or compliance roles is preferred
- Familiarity with pharmaceutical systems and organizational structures
- Understanding of country/cluster regulatory requirements and trends
- Multilingual capability is an advantage
Benefits
Comp & perks- Hybrid work location assignment
- Equal opportunity employer
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsDossier PreparationQuality CompliancePharmaceutical Systems FamiliarityProblem SolvingAudit ReadinessSubmission-Ready Content CreationHealth Authority Query ResponseRegulatory Operational ActivitiesUnderstanding of Regulatory Requirements
Soft Skills
Ability to Work IndependentlyManaging Ambiguity
Certifications
Bachelor’s Degree in PharmacyBachelor’s Degree in Life Sciences
