Regulatory Affairs

PT SKPLASMA CORE INDONESIA; Jakarta Utara; On-site; IDR 167,400,000 - 290,160,000; Full time

Job summary

PT SKPLASMA CORE INDONESIA, part of SK Group, seeks an experienced regulatory affairs specialist to manage BPOM registrations, re-registrations, and variations for biopharmaceutical products. You will be the main regulator liaison, preparing dossiers and ensuring compliance across BPOM, Ministry of Health, and related local authorities.

The role involves cross-functional collaboration with QA, QC, Manufacturing, and R&D, handling change controls, post-approval commitments, and timely submissions

Qualifications

• Bachelor's degree in Pharmacy, and registered pharmacist preferred.
• 3–5+ years of experience in pharmaceutical/regulatory affairs (Specialist/Senior level).
• Strong BPOM/regulatory knowledge and cross-functional collaboration.

Responsibilities

• Manage BPOM registrations, re-registrations, and variations.
• Prepare, compile, review, and submit regulatory dossiers.

Education

Bachelor's degree in Pharmacy

Registered Pharmacist (Apoteker)

Biology/Biotechnology degrees may be considered

Job description

Manage product registration, re-registration, and variations for biopharmaceutical products with the Indonesian National Agency of Drug and Food Control (BPOM). Act as the main contact person between the company and regulatory authorities, ensuring all company activities comply with BPOM, Ministry of Health, and other applicable local regulatory requirements.

Role Description

Product Registration

Manage product registration, re-registration, and variations for biopharmaceutical products with the Indonesian National Agency of Drug and Food Control (BPOM).

Prepare, compile, review, and submit regulatory dossiers.

Regulatory Compliance

Ensure all company activities comply with BPOM, Ministry of Health, and other applicable local regulatory requirements.

Monitor changes in regulations and guidelines, conduct regulatory gap analysis, and communicate regulatory impacts to internal stakeholders.

Regulatory Authority Liaison

Act as the main contact person between the company and regulatory authorities (BPOM, Ministry of Health, and related institutions).

Attend meetings, respond to deficiency letters, clarification requests, and support regulatory audits or inspections as required.

Product Lifecycle Management

Manage regulatory aspects of product changes (change control) related to formulation, manufacturing process, manufacturing site, labeling, and packaging.

Handle post-approval commitments, renewals, and coordinate with pharmacovigilance activities when relevant.

Labeling & Promotional Material Review

Review and approve product labeling (package inserts, IFU, outer packaging).

Ensure promotional and medical materials comply with applicable regulations.

Cross-Functional Collaboration

Work closely with QA, QC, Manufacturing, Supply Chain, R&D, and Medical teams.

Provide regulatory input from product development through commercialization stages.

Documentation & Data Management

Maintain accurate, complete, and audit-ready regulatory documentation.

Manage regulatory databases, product license tracking, and submission timelines.

Job Requirements (Qualifications)

Education

Bachelor's degree in Pharmacy; Registered Pharmacist (Apoteker) is highly preferred.

Degrees in Biology, Biotechnology, or related scientific fields may be considered depending on experience level.

Experience

3–5+ years of experience in pharmaceutical or biopharmaceutical regulatory affairs (Specialist/Senior level).

Hands‑on experience with BPOM registration for biological/biopharmaceutical products is a strong advantage.

Technical Knowledge & Skills

Strong understanding of BPOM regulations, CPOB (GMP), CDOB, and relevant guidelines.

Familiarity with ACTD/CTD, variation management, and post‑marketing regulatory requirements.

Knowledge of biopharmaceutical product development and lifecycle management.

Experience with BPOM e‑registration systems is a plus.

Soft Skills

High attention to detail and strong organizational skills.

Ability to work under tight timelines and manage multiple submissions.

Good communication and negotiation skills, especially with regulatory authorities.

Strong analytical thinking and problem‑solving ability.

Able to work independently and in cross‑functional teams.

Language Skills

Bahasa Indonesia: Fluent (written and spoken).

English: Proficient; able to read, understand, and prepare technical and regulatory documents.

Korean: will be more preferred

SK Plasma Core Indonesia, part of South Korea's SK Group, is a biopharmaceutical company specializing in plasma‑derived medicines that treat hemophilia, immune deficiencies, and severe bleeding disorders. In partnership with Indonesia's Ministry of Health, SK Plasma is establishing a plasma fractionation plant in Indonesia to secure local production of life‑saving treatments. More than a single project, SK Plasma is committed to building a sustainable presence by transferring expertise, supporting plasma donation programs, and ensuring reliable access to vital medicines made from plasma donated by Indonesians, for Indonesians.