Head of Regulatory - Aesthetic Business

Job Description

• Lead the Regulatory Affairs function for the Aesthetic Business and ensure compliance with applicable Kemenkes/MOH, BPOM, and other regulatory requirements.

• Develop regulatory strategies for new product registrations, amendments, renewals, importation, distribution, and product lifecycle management.

• Assess regulatory feasibility for new products and provide clear recommendations on requirements, timelines, risks, and business implications.

• Review technical dossiers, administrative documents, and supporting materials to ensure submission readiness and compliance.

• Manage regulatory submissions and coordinate closely with regulatory authorities, overseas principals, manufacturers, and internal stakeholders.

• Monitor regulatory developments and advise the business on changes that may impact the Indonesian aesthetics market.

• Oversee post-market regulatory activities, including product recalls, FSCA, adverse-event reporting, product destruction, and distribution reporting.

• Ensure company and product licenses remain valid and regulatory requirements related to labelling, advertising, storage, and distribution are properly implemented.

• Support and maintain relevant quality management systems, including ISO 13485.

• Lead, coach, and develop the Regulatory Affairs team while managing multiple regulatory projects and priorities.

Qualifications

• Bachelor’s Degree in Pharmacy, Science, Life Sciences, or related field; Pharmacy background is preferred.

• Minimum 10 years of experience in Regulatory Affairs, preferably within aesthetics, medical devices, pharmaceuticals, cosmetics, or healthcare.

• Proven experience managing or leading a Regulatory Affairs team/function.

• Strong working knowledge of Indonesian Kemenkes/MOH and BPOM requirements, including product registration, importation, distribution, and post-market compliance.

• Hands-on experience reviewing technical dossiers, managing regulatory submissions, and communicating with regulatory authorities.

• Experience working with overseas principals, manufacturers, or regional/global regulatory teams.

• Strong ability to assess new product feasibility and translate regulatory requirements into clear recommendations, timelines, and risks.

• Strong awareness of regulatory developments and their implications for the Indonesian aesthetics market.

• Familiarity with ISO 13485 and relevant quality management systems is an advantage.

• Strong communication skills in Bahasa Indonesia and English.

• Agile, proactive, solution-oriented, and able to manage multiple priorities in a fast-paced environment.

• Strong leadership, stakeholder management, analytical thinking, and attention to detail.