Job Description
Full details about the role and requirements
Yukerja Summary
The Senior Regulatory Affair (Apoteker) role at RecruitGo is curated from JobStreet (category Teknologi & IT). Note the work location (South Jakarta, Jakarta) before applying. Yukerja.com is not the employer — applications are handled on the official source site.
Job description
Develop regulatory strategies for market entry, licensing, and product registration.
Conduct regulatory gap analysis and compliance assessments.
Prepare regulatory timelines and project plans.
Manage end-to-end regulatory submissions for Cosmetic Product; Medical Devices; Food Product Registration; inclusive to Reviewing technical documents, Preparing submission dossiers, Coordinating document legalization when required.
Act as the primary liaison with relevant government agencies
Manage multiple client projects simultaneously.
Monitor new regulations and policy updates.
Ensure all submissions comply with applicable regulations.
Develop and improve Standard Operating Procedures (SOPs).
KPI
Achieve at least 95% on-time completion of all assigned regulatory projects.
Ensure all regulatory submissions are submitted before the agreed client deadline.
Monitor project timelines and proactively escalate potential delays.
Ensure all submission dossiers are complete, accurate, and compliant before submission.
Monitor new and updated regulations relevant to client industries.
Effectively manage multiple regulatory projects simultaneously.
Identify potential regulatory risks at an early stage.
Maintain professional competency by participating in regulatory training and seminars.
Any specific skills, experience, or education requirement
Bachelor's Degree (S1) in Pharmacy.
Willingness for its Indonesian pharmacist license (STRA) to be used as PJT (Company Representative for BPOM
Additional certifications in Regulatory Affairs, Quality Management, or Project Management are an advantage.
Minimum 3 years of experience in Regulatory Affairs, preferably within a regulatory consulting firm, pharmaceutical company, cosmetic company, medical device company, or healthcare industry.
Experience managing multiple regulatory projects simultaneously.
Experience communicating and coordinating directly with government authorities.
Kindly Apply here for better screening: https://draft.jobs/careers/emerhub-consulting-indonesia/senior-regulatory-affair-apoteker