Global Regulatory Affairs Specialist, Compliance & Strategy

PT Philips Indonesia; Daerah Khusus Ibukota Jakarta; Hybrid; IDR 250,000,000 - 450,000,000; Full time

Job summary

Philips Indonesia is seeking a Regulatory Affairs Specialist to ensure compliance with global and country-specific regulatory requirements. You will monitor industry updates, develop regulatory strategies, and manage country registrations to support market access.

You will collaborate across functions, prepare submissions for new products and lifecycle changes, and provide guidance throughout product development while maintaining audit-ready documentation and strong stakeholder relationships.

Qualifications

• Bachelor's degree or higher in a related field.
• At least 3 years of Regulatory Affairs experience in healthcare.
• Proactive with strong communication and compliance mindset.
• Proficient in English and Bahasa Indonesia, written and spoken.

Responsibilities

• Monitor global regulatory requirements, standards and trends.
• Develop and support global regulatory strategies.
• Manage country-specific product registrations and regulatory submissions.
• Prepare regulatory submissions for new products and lifecycle changes.
• Provide regulatory guidance during development and assess compliance/risk.
• Engage with regulatory authorities, industry bodies and internal stakeholders.
• Maintain regulatory documentation, databases, metrics and audit readiness.
• Drive process improvements and communicate regulatory updates to stakeholders.

Skills

Regulatory affairs

Global regulations

Data analysis

Stakeholder comms

Regulatory submissions

Documentation

Education

Bachelor's degree in related field

Job description

Philips Indonesia is seeking a Regulatory Affairs Specialist to ensure compliance with global and country-specific regulatory requirements. You will monitor industry updates, develop regulatory strategies, and manage country registrations to support market access.

You will collaborate across functions, prepare submissions for new products and lifecycle changes, and provide guidance throughout product development while maintaining audit-ready documentation and strong stakeholder relationships.