Temporary Regulatory Affairs Specialist - Hanoi

Please apply using the link below: https://ferring.wd3.myworkdayjobs.com/Ferring/job/Hanoi-Vietnam/Temporary-Regulatory-Affairs-Specialist_R0035853

Please apply using the link below: https://ferring.wd3.myworkdayjobs.com/Ferring/job/Hanoi-Vietnam/Temporary-Regulatory-Affairs-Specialist_R0035853

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