Regulatory Affairs Manager: Lead Compliance & Submissions

Dental 21; Jawa Barat; On-site; IDR 350,000,000 - 700,000,000; Full time

Benefits offered by this job

Career development opportunities

Global corporation culture

Equal opportunity and inclusive work

Job summary

Fresenius Medical Care in Jakarta Utara is seeking a Regulatory Affairs Manager to lead regulatory strategy, submissions, and lifecycle activities for pharmaceutical and medical device products. You will collaborate with internal teams and regulators to ensure compliance and timely registrations.

The role emphasizes pharmacovigilance, labeling reviews, and post-market surveillance, with a strong focus on patient safety and regulatory excellence across the region.

Qualifications

• Minimum 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical, medical device, biotechnology, or healthcare industry.
• In-depth knowledge of pharmaceutical and medical device regulations, registration requirements, and lifecycle management processes.
• Demonstrated success in managing regulatory strategy, regulatory authorities, product registrations, lifecycle management, and pharmacovigilance across multiple products or markets.
• Strong capability to influence senior stakeholders and provide regulatory guidance to leadership teams.

Responsibilities

• Prepare regulatory submissions to authorities (Ministry of Health, NADFC/BPOM, and others) in a timely, compliant manner.
• Lead regulatory strategy and lifecycle activities for pharma and medical devices across markets.
• Coordinate with internal teams and external regulators, and manage regulatory files and databases.
• Support audits, labeling reviews, and post-market surveillance as needed.

Skills

Regulatory strategy

Regulatory submissions

Pharmacovigilance

Cross-functional leadership

Stakeholder management

Job description

Fresenius Medical Care in Jakarta Utara is seeking a Regulatory Affairs Manager to lead regulatory strategy, submissions, and lifecycle activities for pharmaceutical and medical device products. You will collaborate with internal teams and regulators to ensure compliance and timely registrations.

The role emphasizes pharmacovigilance, labeling reviews, and post-market surveillance, with a strong focus on patient safety and regulatory excellence across the region.