Remote Regulatory Affairs Manager at Jobgether – Indonesia

Remote Regulatory Affairs Manager

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Remote Regulatory Affairs Manager. In this role, you will play a crucial part in overseeing the regulatory affairs activities associated with the lifecycle management of pharmaceutical products. Your expertise will ensure that products are compliant with all regulatory requirements, facilitating a smoother process for market development and product maintenance. You'll collaborate across teams to streamline submission strategies and maintain the integrity of product information. This essential role will have a direct impact on improving the lives of people and animals globally.Accountabilities

• Manage regulatory affairs activities for the lifecycle of pharmaceutical products.
• Support change applications including submission strategy.
• Compile dossiers and prepare necessary documentation.
• Conduct content reviews of relevant regulatory documents.
• Ensure compliance of product information and artworks.
• Facilitate Marketing Authorization withdrawals and holder transfers.
• Renew licenses and contribute to Periodic Safety Update Reports.
• Maintain databases for regulatory compliance and communications.

Requirements

• Bachelors or Masters degree in Pharmacy, Life Sciences, or related field.
• Minimum of 5 years experience in regulatory affairs in pharmaceuticals or healthcare.
• Strong project management and stakeholder engagement skills.
• Ability to work independently in a fast-paced environment.
• Proven ability to manage multiple projects simultaneously.

Benefits

• Eligibility for benefits aligned with local market practices.
• Flexible work arrangements to support work-life balance.
• Opportunities for professional development and growth.
• Supportive and inclusive company culture.

Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.#LI-CL1