Aesthetic Doctor

Pt Guna Prakasa Utama; Jawa Barat; On-site; IDR 167,400,000 - 312,480,000; Full time

Job summary

Fresenius Medical Care in Indonesia seeks a Regulatory Affairs Manager to ensure regulatory compliance and oversee submissions to local health authorities. The role requires maintaining licenses, registrations, and adherence to global safety standards across the lifecycle of products.

The candidate will coordinate pharmacovigilance activities, monitor safety signals, and collaborate with cross-functional teams to support product approvals and lifecycle management in a regulated market.

Qualifications

• Regulatory submissions to Indonesian health authorities and maintenance of licenses.
• Support pharmacovigilance activities and device/drug safety compliance.
• Collaborate with internal teams to ensure lifecycle management.

Responsibilities

• Prepare regulatory submissions and annual reports for authorities.
• Maintain regulatory files and licenses; renewals and registrations.
• Oversee pharmacovigilance operations for marketed products.
• Lead communications with health authorities to resolve regulatory issues.

Job description

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Regulatory Affairs Manager

Posted 6 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:**
Regulatory
+ To prepare regulatory submission, annual reports and ensure the authority requirements on registrations processes and procedures. Create and maintain regulatory files.
+ To ensure registered products are compliant to applicable medical device and drug regulations per jurisdiction, guidance, and standards.
Pharmacovigilance
+ To manage and oversee the Pharmacovigilance Operation (PVO) in ensuring compliance with global/local regulatory requirements and FME SOPs for pharmacovigilance of FME marketed products.
**Key Responsibilities / Accountabilities:**
Regulatory
+ Prepare (write, analyze, and edit) and execute regulatory submissions in a format consistent with applicable guidance documents to the authority (Ministry of Health, NADFC/BPOM(Indonesian FDA), Ministry of Law and Human Rights, and other foresees in the future)
+ Work collaboratively with other departments and act as point of contact with third-party in communicating the submission requirements when documents are needed for regulatory submission.
+ Maintain regulatory files and establish databases for all licenses. Maintain and update regulatory authorizations, assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
+ Prepare response to regulatory authorities any inquiries/deficiency questions within assigned timelines.
+ Develop regulatory strategies for variation applications for registered pharma and medical device products.
+ Stay abreast of regulatory procedures and changes in regulatory climate.
+ Communicate to key internal stakeholders any update in the regulations, issues and risk that may affect business operations in the country.
+ Lead negotiations with health authorities during development, registration, and product lifecycle activities to resolve regulatory issues/negotiate approvals and proactively report the status to direct superior and Country Head or key internal stakeholders.
+ Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner.
+ Provide recalls report to authority (