Regulatory Affairs Manager

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 (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 products authorized in the country;
• To share all regulatory requirement updates to affected local functional areas to internal stakeholders and Country Head;
• Ensure timely submission of PSURs to health authorities and provide feedback to Corporate DRA and CDS, as necessary;
• Upload local case/s and forward all safety related information to CDS in a timely manner;
• Follow up on missing case information to the reporter, determine the appropriateness of local ICSR reporting to the local governing body, document all case management activities, and archive all information received;

Others

• Other projects/tasks those may assign by Direct Superior
• Follow the health and safety guideline as per guided by Crisis Management team when doing his/her job inside or outside the organization.
• Follow the Fresenius Medical Care Compliance and Company Regulation/Policy

Your Profile:

• 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 activities across multiple products or markets.

• Strong capability to influence senior stakeholders and provide regulatory guidance to leadership teams.

• Strong understanding of local pharmacovigilance regulations, regulatory intelligence, emerging regulatory trends, and changing compliance requirements.
• Experience establishing and maintaining regulatory systems, databases, SOPs, and governance frameworks.
• Strong project management skills with the ability to manage multiple priorities in a fast-paced environment.

• High level of business acumen with the ability to balance regulatory compliance and commercial objectives.
• Excellent organizational skills and attention to detail.

• Highly accountable with strong ethics and integrity.
• Resilient and adaptable in a dynamic regulatory environment.
• Results-driven with a proactive and solution-oriented mindset.
• Committed to patient safety, product quality, and regulatory excellence.

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world.
• Individual opportunities for self-determined career planning and professional development.
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one.
• A large number of committed people with a wide range of skills, talents and experience.
• The benefits of a successful global corporation with the collegial culture of a medium-sized company.