Regulatory Affairs Manager

Freseniusmedicalcare; Jakarta Selatan; On-site; IDR 420,000,000 - 720,000,000; Full time

Job summary

Fresenius Medical Care Indonesia seeks a regulatory compliance and pharmacovigilance professional to manage submissions to health authorities, maintain licenses, and ensure adherence to safety standards across products and markets.

You will collaborate with internal teams and regulators to support approvals, lifecycle management, labeling reviews, and audits, with potential duties as Deputy QPPV and Company Responsible Pharmacist as required.

Responsibilities

• Prepare (write, analyse, and edit) regulatory submissions to authorities (Ministry of Health, NADFC/BPOM, Ministry of Law and Human Rights) and ensure format compliance.
• Communicate submission requirements with internal teams and third parties to support regulatory filings.
• Maintain regulatory files, licenses, registrations, renewals, and device listings across regions.
• Prepare responses to inquiries/deficiency questions within assigned timelines.
• Develop regulatory strategies for variation applications for pharma and medical device products.
• Stay updated on regulatory procedures and changes; communicate updates to stakeholders.
• Lead negotiations with health authorities during development, registration, and lifecycle activities.
• Assess device-related incidents/complaints for medical device reporting and recalls when needed.
• Support external regulatory audits with regulatory input; review product labels and promotional material for compliance.
• Assist in listing communications and respond to authority inquiries; act as Company Responsible Pharmacist if required.

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, analyse, 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 (Ministry of Health, NADFC/BPOM) and field actions, as required.


• Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.


• Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.


• Assist in communicating enquiries, feedbacks, and any related updates in related to product listing process to organization, as well as assisting in providing respond to authority.


• Act as Company Responsible Pharmacist if required.

Corporate Drug Safety & Pharmacovigilance

• As permanent member of country Qualified Pharmacovigilance Responsible Person (QPPV) - as the Deputy


• Assist to implement Global/AP drugs policy and guideline in the country and local regulatory


• Support to conduct the investigation when there is a Drug Adverse Event with the coordination of Head of Medical


• Assist to conduct drug post market surveillance


• Support to Provide the SOP and training drugs safety to employees involve


• Responsible for determining the screening strategy to be used for local literature screening for all FME product