Temporary Regulatory Affairs Specialist

4 days ago

Ferring Vietnam Ferring Full time $40,000 - $80,000 per year
Job Description:

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

Location:Ferring Vietnam

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