Senior Associate Counsel, Regulatory & Ip (Singapore)

Pt. Garena Indonesia; Jawa Barat; Vor Ort; IDR 350.000.000 - 550.000.000; Vollzeit

Zusammenfassung

Fresenius Medical Care is seeking a Regulatory Affairs Manager in Indonesia to manage regulatory compliance and submissions to the Indonesian health authorities, ensuring licenses and registrations are up to date and that labeling and promotional materials meet local and global standards.

The role requires close collaboration with internal teams and external regulators to support product approvals, lifecycle management, and overall business operations, including pharmacovigilance activities and

Qualifikationen

• Regulatory compliance and submissions to Indonesian health authorities.
• Maintain licenses and product registrations.
• Support product labeling and promotional materials; oversee pharmacovigilance activities.

Aufgaben

• Monitor adverse events and support audits.
• Collaborate with internal teams and regulators to obtain approvals.
• Lifecycle management and overall business operations support.

Jobbeschreibung

Regulatory Affairs Manager

Posted 8 days ago

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Job Description

**_Introduction section:_**
At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision-"Creating a future worth living. For patients. Worldwide. Every day."-we work with purpose and compassion, supported by a global team of over 125,000 employees.
Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
Our values guide how we work:
+ We Care for our patients, each other, and our communities
+ We Connect across teams and borders to deliver excellence together
+ We Commit to doing things the right way- growing with purpose and leading kidney care with integrity and innovation
**Role Summary:**
Responsible for regulatory compliance and submissions to Indonesian health authorities, maintaining licenses and product registrations, and ensuring adherence to local and global drug safety standards. The role includes monitoring adverse events, supporting audits, managing product labeling and promotional materials, and acting as Deputy Qualified Pharmacovigilance Responsible Person. Strong collaboration with internal teams and external regulators is essential to support product approvals, lifecycle management, and overall business operations.
**Your Responsibilities:**