Regulatory Affairs Specialist

Regulatory Affairs Specialist Job Description

• Product Registration

1. Manage product registration, re-registration, and variations for biopharmaceutical products with the Indonesian National Agency of Drug and Food Control (BPOM).
2. Prepare, compile, review, and submit regulatory dossiers.

• Regulatory Compliance

1. Ensure all company activities comply with BPOM, Ministry of Health, and other applicable local regulatory requirements.
2. Monitor changes in regulations and guidelines, conduct regulatory gap analysis, and communicate regulatory impacts to internal stakeholders.

• Regulatory Authority Liaison

1. Act as the main contact person between the company and regulatory authorities (BPOM, Ministry of Health, and related institutions).
2. Attend meetings, respond to deficiency letters, clarification requests, and support regulatory audits or inspections as required.

• Product Lifecycle Management

1. Manage regulatory aspects of product changes (change control) related to formulation, manufacturing process, manufacturing site, labeling, and packaging.
2. Handle post-approval commitments, renewals, and coordinate with pharmacovigilance activities when relevant.

• Labeling & Promotional Material Review

1. Review and approve product labeling (package inserts, IFU, outer packaging).
2. Ensure promotional and medical materials comply with applicable regulations.

• Cross-Functional Collaboration

1. Work closely with QA, QC, Manufacturing, Supply Chain, R&D, and Medical teams.
2. Provide regulatory input from product development through commercialization stages.

• Documentation & Data Management

1. Maintain accurate, complete, and audit-ready regulatory documentation.
2. 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

• Multinational Company Environment
• SK Management Work Culture
• Competitive Salary
• Social Insurance Fully Paid by Company
• Private Insurance Fully Paid by Company
• Annual Bonus based on Performance