Senior Manager, Regulatory Affairs - Remote

Overview

The Senior Manager, Regulatory Affairs will play a crucial role in supporting regulatory submissions and ensuring compliance with local regulations in Indonesia, contributing to the health and safety of the community.

In Short

• Support change applications including submission strategy.
• Compile dossiers and prepare necessary documentation.
• Review content for regulatory compliance.
• Manage local regulatory requirements and maintain databases.
• Communicate with local Health Authorities on behalf of clients.
• Support the Country RA Head in issue management.
• Ensure compliance with medicinal product licenses.
• Engage in cross-functional communication with relevant departments.
• Contribute to promotional material reviews.
• Work within a team committed to health improvement.

Requirements

• Life Science Degree, preferably in Pharmacy.
• 5-10 years of experience in Regulatory Affairs.
• Knowledge of Health Authority requirements.
• Experience in lifecycle management of medicinal products.
• Strong communication skills.
• Ability to manage artwork and supply strategy.
• Experience in regulatory strategy for submissions.
• Familiarity with local regulatory intelligence.
• Ability to work collaboratively across functions.
• Proficiency in managing compliance issues.

Benefits

• Competitive salary and benefits package.
• Opportunity to work in a purpose-driven organization.
• Supportive work environment focused on health improvement.
• Career growth opportunities within a global company.
• Engagement in meaningful work that impacts lives.
• Access to training and development resources.
• Flexible working conditions.
• Commitment to diversity and inclusion.
• Employee support programs.
• Global networking opportunities.