Regulatory Affairs Director, Submission and Operations
- Shanghai, Taiwan, Malaysia
- Full Time
- On-site
-
Posted On: January 09, 2025
As the Director of Regulatory Affairs for Submission and Operations, the candidate will lead and manage the planning and execution of regulatory central/core dossiers, submission procedures, compliance reporting, and document archiving.
Primary duties and responsibilities
- Submission Leadership: Lead, develop, and manage global core dossiers (mainly M2-M5) to enable the successful submission of respective products in relevant markets.
- Regulatory Strategy for Operations: Lead regulatory strategies for operative activities (submission, reporting, CTD/eCTD readiness, etc.) to enable timely and successful submissions in respective markets.
- Regulatory Submissions: Oversee the preparation, submission, and approval process for regulatory filings, including NDA/BLA/MAA, medical devices, and supplements.
- Regulatory Compliance: Monitor regulatory developments and provide guidance to ensure compliance with product post-approval reporting responsibilities and the implementation of required periodic submissions/reporting.
- Policy Development: Develop and implement regulatory policies, SOPs, and best practices to support submissions and operations in compliance with regional and country-specific guidelines.
- Agency Interaction: Establish and maintain relationships with regulatory agencies for submission and compliance activities, respond to technical inquiries, and effectively communicate submission-related matters.
- Team Leadership: Manage and develop a high-performing regulatory team, ensuring the timely delivery of set goals and milestones.
- Communication: Effectively communicate regulatory strategies, planning, risks, and recommendations to RA Project Leads, project management, other functions, and senior management.
- Resource Management: Ensure appropriate levels of resources and manage the submission and archiving budget.
Qualifications
- Bachelor of Science with at least 15+ years of experience in regulatory submission and archiving, including at least 10+ years in global submission management, such as NDA/BLA/MAA experience using eCTD, CTD, and/or ACTD; or
- Master of Science with 12+ years of experience in regulatory submission activities and archiving; or
- Ph.D., Pharm.D., or M.D. in Sciences with at least 8+ years of experience in regulatory submission and archiving.
- Global submission experience with NDA/BLA/MAA and post-approval compliance reporting using eCTD, CTD, and/or ACTD is a must.
- Dossier preparation and submission experience in countries/markets in Southeast Asia, the Middle East, and the APAC region is a must.
- Knowledge of US, EU, China, and APAC regulations and related global regulations is highly preferred.
- Experience in central dossier preparation and dossier archiving in the APAC region/countries is highly preferred.
- Experience in cross-functional due diligence for product license-in is preferred
- Leadership skills and subject-matter expertise.
- Project management skills, including cross-functional communication, interpersonal, and influence-management abilities.
- A strong team player with excellent communication skills (both verbal and written) and strong analytical capabilities.
- Ability to work effectively with regulatory teams and project teams across different locations and time zones.
