(Senior) Regulatory Affairs Specialist
Core
Ensure regulatory compliance and facilitate the successful execution of clinical trials to bring new medicines and treatments to patients.
Role type
Senior Regulatory Affairs Specialist (Pharmaceuticals/Medical Devices)
Builds
Product registrations, operational licenses, and regulatory submissions for assigned portfolios.
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory planning and submission management, local registration plan design, regulatory intelligence collection, health authority interaction, promotional material compliance review, audit and inspection readiness support, database management.
Preferred skills
Drug development knowledge, National Drug Regulations expertise, English proficiency.
Technologies
e-MLR systems, regulatory databases.
Responsibilities
Manage regulatory tasks and projects to attain and maintain product licenses; prepare and submit regulatory applications for timely approval; monitor submission progress and coordinate responses to health authorities; collect and share new local regulations and guidelines; ensure compliance with corporate policies and local change control procedures; provide regulatory consultation to local business stakeholders; participate in promotional material approval processes; submit periodic safety reports (PSUR) and renewals; maintain up-to-date regulatory databases.
Seniority
Senior, hands-on IC