Assistant manager - Regulatory Affairs

Company Description

Chemill Pharma Ltd. is a mission-driven pharmaceutical company operating in both the public and private sectors. Headquartered in HongKong, We provide high-quality, affordable generic drugs for healthcare authorities and develop innovative healthcare solutions for social and lifestyle issues affecting local populations. With a lean organization model, we focus on delivering impactful outcomes, resulting in success and a growing number of opportunities.

Role Description :

1)   Evaluate product feasibility by reviewing Product compliance checklists for Hong Kong and Singapore markets and provide recommendations to the Business Development team.

2)   Perform detailed technical and administrative review of dossiers in line with Hong Kong and Singapore regulatory requirements (e.g., CTD/ACTD formats).

3)   Plan and ensure timely submission of dossiers, especially in alignment with tender deadlines.

4)   Coordinate with internal teams and external business partners to obtain, track, and close pending dossier documents.

5)   Prepare and review labelling components including artworks (cartons, foils, and pack inserts) as per country-specific regulatory guidelines.

6)   Develop and review Product Information (PI), Patient Information Leaflet (PIL), and Risk Management Plan (RMP) in alignment with innovator products and Hong Kong requirements.

7)   Compile, review, and submit high-quality dossiers for registration in Hong Kong and Singapore.

8)   Assess regulatory queries/deficiencies received from authorities and prepare scientifically sound responses within defined timelines.

9)   Liaise with local agents/partners for submission, query handling, and approval tracking.

10) Provide support to the Hong Kong regulatory team as required.

11) Maintain and update the status of dossiers and regulatory queries in tracking systems.

12) Support lifecycle management activities such as variations, renewals, and compliance updates.

13) Promote transparency, accountability, and a proactive work culture within the department.

14) Ensure adherence to internal SOPs, regulatory guidelines, and quality standards.

15) Execute tasks assigned by senior management with integrity and professionalism.

16) Provide regulatory intelligence updates relevant to Hong Kong and Singapore markets.

Experience:

• 5–8 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Hands-on experience with dossier preparation and submission for Hong Kong and/or Singapore markets.
• Experience in handling regulatory queries and lifecycle management.
• Familiarity with ASEAN, CTD/ACTD formats, and international regulatory guidelines is preferred.

Key Skills & Competencies:

• Strong knowledge of Hong Kong and Singapore regulatory requirements.
• Expertise in dossier compilation, review, and submission.
• Good understanding of PI, PIL, and labeling/artwork requirements.
• Excellent coordination and stakeholder management skills.
• Strong analytical and problem-solving abilities.
• Effective communication and documentation skills.
• Ability to manage multiple projects and meet strict deadlines.