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Regulatory Affairs Specialist (Southeast Asia Market)

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磐悅亞太
Medical / Pharmaceutical
Posted 3 months ago
HK $20K-50K/Month
Bachelor
3 to 5 years
Full Time
9.0 hrs/day, Negotiable working days

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Job DescriptionTranslate to English
[Job Responsibilities]

1. Based on the company's product characteristics and R&D progress, develop and implement drug registration strategies and application plans for Southeast Asian countries;

2. Lead or assist in completing the company's product registration in Vietnam, Thailand, Malaysia, Indonesia, the Philippines, etc., including data collection, submission and follow-up communication;

3. Continuously track and interpret the pharmaceutical regulatory policies and technical standards of Southeast Asian countries, and provide registration and compliance consulting services;

4. Coordinate internal teams (business, legal, marketing, etc.) to support product overseas listing and project cooperation;

5.

6. Regularly output policy updates, registration progress reports, and risk advice.

[Job Requirements]

1. Medical, pharmacy, biology, chemistry, etc. related professional bachelor's degree or above;

2. At least 3 years of pharmaceutical registration work experience, those with successful registration cases in Southeast Asian countries are preferred;

3. Familiar with the drug registration process and regulatory requirements of Vietnam, Thailand, Malaysia, Indonesia, etc.;

4. Able to write and review registration information, with good reading and writing skills in Chinese and English;

5. Proactive, with good cross-departmental coordination and time management skills;

6. Accept remote cooperation, and be able to complete registration tasks according to project milestones.

[We provide]

• Flexible work arrangements (full-time or part-time) ;

• Professional platforms with international cooperation background and registered project resources;

• Stable returns and a competitive compensation system (subject to negotiation);

• Long-term cooperation opportunities and development space.

Key Responsibilities

1. Develop and execute drug registration strategies for Southeast Asian countries based on product features and development stages;

2. Lead or support product registration submissions in countries such as Vietnam, Thailand, Malaysia, Indonesia, and the Philippines — including dossier preparation, submission, and follow-up;

3. Monitor and interpret evolving regulatory policies and technical standards in SEA countries and provide internal consultation;

4. Collaborate with cross-functional teams (BD, legal, marketing) to support product launch and partnerships;

5. Build and maintain working relationships with local regulatory agents, consultants, and competent authorities;

6. Provide regular updates, project progress reports, and risk analysis related to registration timelines.

Requirements

1. Bachelor’s degree or higher in Pharmacy, Medicine, Biology, Chemistry, or related disciplines;

2. Minimum of 3 years’ experience in drug registration, with successful case experience in Southeast Asia preferred;

3. Strong familiarity with drug registration processes and regulatory requirements in countries such as Vietnam, Thailand, Malaysia, and Indonesia;

4. Able to draft and review regulatory documentation in both Chinese and English;

5. Proactive, organized, and capable of working cross-functionally under deadlines;

6. Comfortable with remote work and able to drive projects independently.

We Offer

• Flexible working model (full-time or part-time);

• Exposure to international markets and professional regulatory resources;

• Competitive compensation and performance-based rewards (negotiable);

• Long-term collaboration and career growth opportunities.


Languages
English
Mandarin
Skills
Pharmacy
Pharmaceutics
Biology
Pharmaceutical

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Sam HR
磐悅亞太 · PANYUE ASIA-PACIFIC LIMITED
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Job Location

133 Wai Yip Street-Kwun Tong, Kwun Tong

號地下, 133 Wai Yip St, Kwun Tong

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Company Overview

International business of pharmaceutical, medical products, healthcare products.


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