Remote Regulatory Affairs Manager

Medium; Remote; IDR 300.000.000 - 500.000.000; Full time

Job summary

A leading life sciences company is seeking a Remote Regulatory Affairs Manager to oversee regulatory activities for pharmaceutical products. This role involves managing compliance, compiling necessary documentation, and ensuring the integrity of product information. Ideal candidates will have a degree in Pharmacy or Life Sciences and at least 5 years’ experience in regulatory affairs. The company offers flexible work arrangements and opportunities for professional development.

Benefits

Eligibility for benefits aligned with local market practices

Flexible work arrangements

Opportunities for professional development and growth

Supportive and inclusive company culture

Qualifications

• Minimum of 5 years’ experience in regulatory affairs in pharmaceuticals or healthcare.

Responsibilities

• 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.

Skills

Strong project management skills

Stakeholder engagement skills

Ability to work independently

Managing multiple projects

Education

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field

Job description

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

• Bachelor’s or Master’s 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.

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