Regulatory Affairs Executive

BUT Mega Life Sciences Pty Ltd; Jakarta Utara; On-site; IDR 240,000,000 - 360,000,000; Full time

Job summary

Mega Lifesciences is seeking a Regulatory Affairs Executive for Export to work with the Regulatory Affairs Manager in a fast-paced environment. Responsibilities include preparing and managing English dossiers and coordinating submissions with destination authorities.

The ideal candidate has a pharmacy degree and 2–3 years in regulatory affairs, with strong English and Bahasa Indonesia communication, attention to detail, and the ability to work across teams in multiple countries.

Qualifications

• Graduate in Pharmacy or related discipline.
• 2–3 years of regulatory affairs experience.
• Experience with drug registration requirements and export submissions.

Responsibilities

• Prepare and manage registration dossiers in English with accuracy and timeliness.
• Coordinate submission and registration with local authorities in destination markets.
• Maintain organized records with data entry and file management.
• Communicate regulatory updates across departments and countries to ensure compliance.

Skills

Detail-oriented

Proactive

English & Bahasa Indonesia

Education

Pharmacy degree

Job description

Do you feel like every day starts at zero?
Are you a highly responsible person?
Do you have a knack for knowing what's important?

Mega Lifesciences is looking for a Regulatory Affairs Executive for Export to work closely with the Regulatory Affairs Manager in a fast-paced environment that offers ample opportunities to learn and expand your experience and expertise.

Job Summary

As a Regulatory Affairs Executive for Export, your key tasks include:

Preparing and managing comprehensive registration dossiers in English with accuracy and timeliness.

Coordinating the submission and registration process with local authorities in the destination markets.

Maintaining organized records by diligently handling data entry and file management tasks.

Communicating regulatory updates across departments and countries to ensure compliance alignment.

Qualification & Experience

Applications are invited from interested candidates who meet the following criteria:

Graduate in Pharmacy or a related discipline.

2–3 years of experience in regulatory affairs or similar roles.

Demonstrated expertise in drug registration requirements and relevant regulations.

Prior experience compiling technical documentation and handling submissions for export markets.

Skills & Knowledge

The ideal candidate is detail-oriented, proactive, and passionate about delivering accurate and timely results in a structured environment. They should have strong typing and communication skills in both English and Bahasa Indonesia, along with sound knowledge of pharmaceutical regulations and drug registration processes. A driven personality, reliability, and focus on priorities will be crucial to succeed in this role.

Mega Lifesciences PCL (listed in Thailand Stock Exchange) is our branded products business under which we develop, manufacture, market and sell our own brand of nutraceutical products, prescription pharmaceutical products and OTC products. We have manufacturing facilities in Thailand, Australia and Indonesia. Since 1982, Mega Lifesciences Public Company Limited is actively involved in helping millions of people have access to safe, effective, world class medicines. We are operating in 34 countries. To continue our expansion in Indonesian pharmaceutical market, we acquired a company this year, building our strength in the country with a strong team of 400 people.