[Hà Nội] Regulatory Sciences Associate

Job summary:

The Regulatory Sciences Associate is responsible for all activities pertaining to product registration, regulatory submissions, and national programs, including registration amendments, drug reports, promotion activities, and company registration/renewals.

He/she is also responsible for developing packaging artworks of registered products, ensuring compliance with company SOPs, and maintaining alignment with relevant legal and regulatory requirements.

In addition, the Regulatory Sciences Associate provides regulatory advice to internal stakeholders.

JOB RESPONSIBILITIES:

1. Regulatory Submission & Approval (renewal, variation, new registrations as assigned)

• Prepare, submit, coordinate, and follow up on product registrations as assigned
• Handle variation registrations (CMC, labeling updates, artwork changes, etc.)
• Ensure timely approvals in line with the product registration plan
• Liaise with relevant stakeholders both locally and internationally
• Provide required information/documents to internal stakeholders and Health Authorities (e.g., Ministry of Health) in compliance with regulations
• Manage amendments to registered products under responsibility

2. Compliance Management

• Ensure compliance with adverse event and quality issue reporting requirements
• Ensure adherence to regulations from the Ministry of Health and other relevant authorities

3. Cross-functional Coordination

• Coordinate with the Supply Chain team to support product availability in the market
• Keep track of regulatory changes and proactively update relevant departments

4. Regulatory Advisory

• Provide professional advice, recommendations, and regulatory input on legal documents to both local and overseas stakeholders

5. Product Advertising & Promotion

• Provide regulatory guidance to Marketing in developing promotional materials in line with SOPs
• Support Marketing in liaising with authorities (e.g., MOH/Hanoi SOH) for urgent approval of promotional activities

6. Packaging Artwork Development

• Coordinate with internal teams and manufacturing sites to develop packaging artworks for assigned products

7. Stakeholder Coordination

• Coordinate with headquarters and external partners as required

8. Others

• Perform other tasks assigned by the Head of Regulatory Sciences (Vietnam)

QUALIFICATIONS / SKILLS:

Qualifications: Bachelor degree in Science or Pharmacy

Skills:

• Preferably 1 year of working experience in a regulatory Sciences environment
• Fluent in English – written and spoken communication skills
• Good knowledge of international or local regulatory guidelines and codes
• Preferably with knowledge across multiple therapeutic areas
• Meticulous nature and proficient in data tracking and consolidation
• Proven ability to consistently deliver to time, cost and quality standards.
• Ability to effectively deliver in a complex matrix environment.
• Computer skill: Microsoft Word, Excel, Power Point, Adobe Illustrator, Adobe Photoshop, Usage other office machine such as: Scanner, Photocopy