Regulatory Affairs Director, Submission And Operations

Regulatory Affairs Director, Submission and Operations
Regulatory Affairs Director, Submission and OperationsFull 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 responsibilitiesSubmission 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 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.
QualificationsBachelor of Sciencewith 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 Sciencewith 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.#J-18808-Ljbffr