Senior Specialist, RA
Core
Local implementation of regulatory and quality activities, obtaining and maintaining marketing authorizations for drugs, biologics, and medical devices in Malaysia.
Role type
Senior Regulatory Affairs Specialist (Drugs, Biologics, Medical Devices)
Builds
Regulatory project plans, marketing authorizations, compliant labeling and promotional materials, SOPs
Domain
Healthcare / Pharmaceutical / Medical Devices / Regulatory Affairs
Required skills
Regulatory project management, risk identification, regulatory document compilation, labeling compliance review, SOP development, regulatory authority liaison, team guidance
Preferred skills
Pharmacist license, experience with new registration/license extensions/variations/renewals, GDPMD knowledge, project management, multitasking
Technologies
Word processing, spreadsheets, databases, online research systems
Responsibilities
Develop and execute regulatory project plans, identify and elevate regulatory risks, respond to regulatory authority inquiries, compile and submit regulatory documents, maintain existing authorizations, prepare and approve labeling and AdProm materials, prepare local SOPs, represent Regulatory Affairs in project teams, guide junior members
Seniority
Senior, hands-on IC with mentorship