High quality HR Consulting Services

Job Profile

Job title Regulatory Affairs Manager Job codeV10152 Salary $1,800 - $2,500 Benefits

Company Policy

Client info

The Multinational Pharmaceutical Company

LocationHa Noi Job Description
  • Making a registration schedule on new register, renewal, changing, import quota
  • Manage the registering new and renewal license
  • Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
  • Ensure that the product information submitted to the authorities is complete timely and in the correct format.
  • Participate in product teams regarding to implementation of regulatory requirements
  • Keep update of the regulations, law and guidelines and regulatory development field, including MOH's regulations.
  • Responsibility for ADR report
  • Support to Marketing team on promotional materials
  • Support to Logistic team on packaging materials in compliance with MOH's regulation
  • Review product labelling for compliance
  • Build up good relationship with Health Authorities: Drug Administration of Vietnam, National Institute of Quality Control, Department of Health Insurance,….
  • Discuss with DRA Head and define the regional RA project planning and time-line development
  • Ensure the execution and management of regulatory affairs projects to achieve the regional (corporate and department) goals.
  • Report to Country Manager and Regional Regulaotry Affairs Director

·         Pharmacy or Medicine University degree

·         Minimum 3 years experience in regulatory function in multinational pharmaceutical industry

·         Good leadership skills – people management

·         Preferably the candidate should be a critical thinker, pay attention to details and be well organized and self-disciplined

·         Good English communication skills

·         Proactive and highly committed to support and deliver results

·         Excellent interpersonal skills

·         High level of integrity and good morals

·         Good skills in Communication, Leadership and Problem solving

·         Planning and organization skills

ContactDiep, Le (Ms.)
+84 8 3821 5096
+84 8 903 859 8