Regulatory Affairs Manager

Purpose of the Role:

Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams, coordinating with global manufacturers, and driving timely submissions and approvals.

This role requires a balance of strategic oversight and hands-on execution, ensuring compliance with regional regulatory frameworks while supporting Chemill’s business growth and product pipeline.

Key Responsibilities:

1. Dossier Review and Evaluation

• Review and evaluate dossiers received from manufacturers in accordance with ASEAN, Hong Kong, and country-specific registration guidelines.
• Ensure documentation completeness, accuracy, and adherence to local regulatory formats.
• Proactively identify gaps and resolve potential issues prior to submission.

2. Compilation and Submission

• Compile dossiers for final internal review & Submit dossiers directly to country-specific regulatory authorities' online platforms as per regulatory requirements.
• Track submissions to ensure timely approval and lifecycle management.

3. Communication and Coordination

• Liaise with manufacturers for document revisions, data updates, and compliance alignment prior to submission.
• Handle regulatory deficiencies and coordinate corrective actions efficiently.
• Serve as the primary communication bridge between Chemill’s RA team, overseas partners, and local authorities.

4. Query & Deficiency Management

• Address CORP and NMPA (or respective ASEAN/HK agency) queries in a professional and timely manner.
• Maintain clear documentation and ensure alignment of responses with company regulatory strategy.

5. Labeling & Artwork Approval

• Review and approve artworks to ensure compliance with Hong Kong’s bilingual (English/Chinese) labeling standards and other ASEAN-specific requirements.
• Coordinate with internal design teams and manufacturers for final artwork approval before submission.

6. Tender Support & Documentation

• Prepare regulatory and compliance documents required for public tenders (Schedule B, USP/BP compliance).
• Coordinate sample arrangements, re-labeling, and regulatory declarations in alignment with business timelines.

7. Regional Team Leadership

• Lead, mentor, and grow the

  Regulatory Affairs team in India

  , setting clear goals, KPIs, and development plans.
• Oversee workload allocation, review performance, and drive accountability for results.
• Foster a collaborative and high-performing regulatory function.

8. Strategic Planning & Coordination

• Develop regulatory roadmaps for new product registrations and renewals in ASEAN & HK.
• Plan submission schedules, monitor progress, and ensure timely completion of all regulatory milestones.
• Collaborate closely with BD, Supply Chain, Quality, and Marketing to support business objectives and product launches.

9. Reporting & Compliance Tracking

• Maintain up-to-date registration trackers and dashboards for ASEAN & HK submissions.
• Generate monthly/quarterly reports for senior management.
• Track renewals, variations, and post-approval changes proactively.
  

Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
• 5–8 years of regulatory affairs experience in the pharmaceutical industry, preferably with exposure to ASEAN and/or Hong Kong markets.
• Proven experience leading teams and managing multi-country submissions.
• Strong understanding of dossier compilation, electronic submission systems, and post-approval lifecycle management.
• Excellent communication, coordination, and stakeholder management skills.
• Proficiency in Microsoft Office, submission tracking tools, and eCTD software.
• Detail-oriented with the ability to manage multiple priorities under tight timelines.
• Willingness to travel when required.

Key deliverables :

• On-time submission and approval of dossiers across ASEAN & HK.
• Reduction in query resolution timelines and documentation gaps.
• Successful onboarding, training, and retention of high-performing RA team members.
• Regular process improvement and optimization of submission workflows.