Temporary Regulatory Affairs Specialist (7 months) - Hanoi
Job Summary:
We are seeking a highly motivated Temporary Regulatory Affairs Specialist to support our team in ensuring the timely and compliant submission and maintenance of our products within a dynamic international regulatory landscape. This role is crucial for managing regulatory documentation and processes, and contributing to our overall regulatory strategy.
Job Responsibilities:
Manage and execute change control processes for regulatory submissions, ensuring compliance with global regulations.
Communicate effectively with internal and external stakeholders, including health authorities and cross-functional teams, regarding regulatory matters.
Contribute to the continuous monitoring of evolving regulatory requirements and guidelines, assessing their impact on company products and processes.
Deliver results by successfully preparing, submitting, and maintaining regulatory dossiers and documentation within established timelines.
Display resilience and adaptability in navigating complex regulatory challenges and evolving priorities.
Oversee and ensure accurate document lifecycle management for all regulatory submissions and supporting documentation.
Manage self effectively, demonstrating strong organizational skills and the ability to prioritize tasks independently.
Apply project management principles to regulatory initiatives, ensuring projects are completed efficiently and effectively.
Identify and mitigate project risk management pertaining to regulatory submissions and activities.
Ensure strict adherence to regulatory compliance standards across all aspects of product development and commercialization.
Navigate and contribute to the efficiency of the regulatory process, identifying areas for improvement.
Support regulatory relationship management with health authorities and other external partners.
Contribute to the development and implementation of regulatory strategy to support product development and market access.
Think and solve problems proactively, identifying solutions to complex regulatory issues.
Work collaboratively with cross-functional teams, including R&D, Quality, and Commercial, to achieve regulatory objectives.
Job Qualifications:
Bachelor's degree in pharmacy
Knowledge of drug regulation and relevant legislation regarding the pharmaceutical regulatory environment preferred
Good knowledge on working process at DAV
English proficiency
Good communication skills
At least 1 year experience on Regulatory Affairs