Regulatory Affairs Specialist (Maternity Cover)

This is a hands-on, 4-6 months part time maternity cover role. You’ll step into live registrations, in-flight applications, ongoing import and distribution compliance, and keep everything moving without disruption. You must be able to walk in with minimal ramp-up, the handover window is roughly 1–2 weeks. You must be based in Jabodetabek, necessary for authority visits, submissions and shipment coordination.

We're looking for someone with a strong desire to make a real impact. You will have a key role and exposure in delivering a compliant Blood business to help extend our reach to our next million users as a period care challenger brand.

Working closely with internal teams and external bodies, you will plan, drive and implement regulatory affairs strategies to comply with local government requirements and company standards in the Indonesian market.

• Act as Blood’s Technical Responsible Person (TRP) in Indonesia and the day-to-day regulatory point of contact for our medical-device portfolio during the cover period
• Manage new product registration (AKL) submissions with Kemenkes (MOH) — including any applications in progress at handover
• Prepare and file change notifications for existing product registrations with Kemenkes
• Handle end-to-end import regulatory documentation to keep commercial shipments clearing smoothly, including Import Report, LHVIU, PERTEK, and PI (Persetujuan Impor)
• Maintain CDAKB compliance across the distribution operation, and own QMS setup/compliance and internal/external audits (e.g. ISO 13485, CE, GDPMD, CDAKB)
• Lead the IDAK / CDAKB / regulatory workstream for the 3PL: ensure our 3PL warehouse is fully IDAK/CDAKB compliant — coordinating the required CDAKB inspection/certification, and updating IDAK and registration records so distribution authorization stays unbroken.
• Liaise with supply chain to ensure product-label compliance on commercial shipments
• Work with Kemenkes and other authorities, certification bodies and auditors, and coordinate internally with Operations, Supply Chain, Production, R&D and QA to resolve regulatory queries
• Stay informed on changes in regulatory laws and work with internal stakeholders to mitigate business impact
• Monitor registration status, renewals, and any regulatory deadlines falling within the cover period, and flag risks early
• Maintain regulatory records and documentation so the returning specialist can pick up seamlessly
• Handle any other regulatory-related matters as required by the company and management

Highly preferred — one of the following degrees or diplomas:

• DIII/S1 Farmasi / Apoteker (Pharmacy / Pharmacist)
• DIII/DIV Analis Farmasi / Analis Farmasi & Makanan (Pharmaceutical Analyst / Pharmaceutical & Food Analyst)
• S1 Kimia (Chemistry)
• S1 Teknik Kimia (Chemical Engineering)
• S1 Teknik Biomedik (Biomedical Engineering)

At least 3 years of Regulatory Affairs experience in Indonesia covering product registrations and life-cycle management (baseline). 6+ years and an independent/consulting track record is strongly preferred — see Level of expertise below

Proven, first-hand track record in Indonesian medical-device RA — not oversight or advisory only. You have personally:

• Filed new product registrations (AKL) with Kemenkes
• Prepared and submitted change notifications to Kemenkes
• Handled import regulatory documentation: Import Report, LHVIU, PERTEK, PI
• Worked within CDAKB and IDAK frameworks — specifically handling IDAK/facility changes (e.g. adding or changing a warehouse, onboarding a 3PL, or a CDAKB premises inspection), not just steady-state compliance

Good understanding of the relevant regulatory, legal and import environment in Southeast Asia, especially Indonesia

Able to operate fully independently with minimal supervision and a short handover

Based in Jabodetabek

Fluent in Bahasa Indonesia and English (written and spoken)

• Prior experience in the beauty, retail, and/or pharmaceutical industry
• Experience with sanitary / personal-care or consumer medical-device products specifically
• Good working relationship with country health authorities (Kemenkes / MoH)
• ISO 13485 / QMS familiarity
• Experience managing a warehouse or 3PL from the regulatory side
• Prior fractional or contract RA work for principals/distributors (i.e. used to parachuting into an existing setup)
• Driven & independent, and open to taking on diverse responsibilities in a dynamic environment