Regulatory Affairs Specialist

Job Title

Regulatory Affairs Specialist

Job Description

Job summary:

The role is responsible for ensuring compliance with global and country-specific regulatory requirements, monitoring industry updates and collaborating across functions.

Your Role

• Monitor global regulatory requirements, standards, and emerging trends to anticipate changes and assess business impact.
• Develop and support global regulatory strategies aligned with product and business objectives.
• Manage country-specific product registrations and regulatory submissions, ensuring accurate documentation and timely approvals.
• Prepare regulatory submissions for new products, product changes, and lifecycle activities to support market access.
• Provide regulatory guidance throughout product development and conduct compliance and risk assessments, including mitigation strategies.
• Build effective relationships with regulatory authorities, industry bodies, internal stakeholders, and external partners.
• Maintain regulatory documentation, databases, metrics, and records to ensure compliance, audit readiness, and performance monitoring.
• Drive regulatory process improvements using lean methodologies and effectively communicate regulatory updates, risks, and recommendations to stakeholders.
  
  

You're The Right Fit If

• Bachelor's degree in related majors.
• Minimum 3 years of experience in Regulatory Affairs related role within healthcare industry.
• Proactive, good at communication skills, being able to deal with complex situations, high responsibilities and good at compliance mindset
• Proficient in English language and Bahasa Indonesia both oral and written.
  
  

Preferred Certification

RAPS RAC certification, Certified associate in project management (CAPM), Six Sigma, Certified Change Management Professional (CCMP) & Transformation-related certification or equivalent.

Preferred Skills: Regulatory Requirements, Global Regulations Monitoring, Data Management, Research & Analysis, Regulatory Agency Liaison, Strategy Implementation, Document Auditing, Product Registrations, Product Labeling, Continuous Improvement, Regulatory Compliance Monitoring, Data Analysis & Interpretation & Operational Excellence Tools.

How We Work Together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

About Philips

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.