Regulatory Affairs Director - Pharmaceuticals - Jakarta Selatan (C-121724)

About The Company:

• The working venue is in South Jakarta.

• Our client is a Japanese Pharmaceuticals company. Currently, they are looking for Regulatory Affairs Director.

Job Responsibilities:

• Develop and implement regulatory strategies for ethical drugs, infusion products, and enteral nutrition.

• Ensure full compliance with BPOM, Ministry of Health, and other relevant authorities.

• Oversee product registration processes before market entry.

• Manage documentation and submission for new product approvals and renewals.

• Act as the primary liaison with BPOM, Kemenkes, and other regulatory channels.

• Represent the company in regulatory meetings and industry forums.

• Work closely with R&D, marketing, supply chain, and finance teams to ensure regulatory alignment.

• Support product research and development from a regulatory perspective.

• Lead and mentor a team of 5 regulatory professionals.

• Ensure team performance, development, and regulatory knowledge are up to date.

• Develop and maintain internal systems for regulatory tracking and approval workflows.

• Ensure efficient handling of inactive product menus and approval systems.

• Other duties as assigned.

Job Requirements:

• Bachelors degree.

• 10 years of experience as Regulatory Affairs from MNC pharmaceutical industry.

• Business level English proficiency.

• Proven experience engaging with BPOM, Kemenkes, and other regulatory bodies.

• Strong understanding of product licensing, compliance, and market entry processes.

[Only CV in English will be processed]

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Information :

• Company : RGF HR Agent Recruitment
• Position : Regulatory Affairs Director - Pharmaceuticals - Jakarta Selatan (C-121724)
• Location : Jakarta
• Country : ID