Regulatory submission preparation for indonesian authorities
Pharmacovigilance operations management
Medical device and pharmaceutical compliance knowledge
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Fresenius Medical Care is seeking an Associate Manager for Regulatory Affairs in Jakarta, Indonesia, responsible for ensuring compliance with local and global regulations related to medical devices and pharmaceuticals. The ideal candidate will have a background in pharmacy or a related field, with at least two years of regulatory experience, and will play a crucial role in product registrations, pharmacovigilance, and collaboration with internal and external stakeholders.
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Job Summary
The role is responsible for ensuring regulatory compliance and managing submissions to Indonesian health authorities like NADFC/BPOM.
As Deputy Qualified Pharmacovigilance Responsible Person, the incumbent will oversee pharmacovigilance operations and manage adverse event investigations.
Fresenius Medical Care offers a global corporate culture with opportunities for professional development and innovative thinking.
Matching Summary
Match Score: 75
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Fresenius Medical Care is seeking an Associate Manager for Regulatory Affairs in Jakarta, Indonesia, responsible for ensuring compliance with local and global regulations related to medical devices and pharmaceuticals. The ideal candidate will have a background in pharmacy or a related field, with at least two years of regulatory experience, and will play a crucial role in product registrations, pharmacovigilance, and collaboration with internal and external stakeholders.
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Skills & Requirements
Must-have
Regulatory submission preparation for Indonesian authorities
Pharmacovigilance operations management
Medical device and pharmaceutical compliance knowledge
Adverse event monitoring and reporting
Product labeling and promotional material review
Nice-to-have
Experience in multinational healthcare companies
Strong stakeholder negotiation skills
Ability to lead cross-functional teams
Proactive regulatory strategy development
Commitment to continuous learning and ethics
Key Requirements
Bachelor's degree in Pharmacy or Science
Minimum 2 years regulatory experience in pharma/device
Knowledge of Indonesian medical device and drug regulations
Experience with pharmacovigilance SOPs and guidelines