Regulatory Affairs Executive (HCM)

Regulatory Affairs Executive (HCM)

Mô tả công việc: 
Ngày cập nhật: 26/07/2019

Thông Tin Tuyển Dụng

Phúc lợi

  • Bảo hiểm theo quy định
  • Du Lịch
  • Thưởng
  • Chăm sóc sức khỏe
  • Đào tạo
  • Tăng lương

Mô tả Công việc

Job Scope

  • Responsible for regulatory submissions and approvals
  • Responsible for regulatory compliance according to local requirement
  • Responsible for reporting, provision of healthcare information, and the approval of advertising/promotional material and DKSH sponsorships

Job Responsibilities

  • Provide the registration service of products to Clients and consult on regulation for relevant depts.
  • Plan and execute regulatory submissions for new products, new indications, renewals and required changes to maintain current registration of all products, in alignment with planned timelines.
  • Maintain global and regional systems and databases to ensure that all relevant regulatory information is updated and reconciled following current approval.
  • Keep abreast of changes in the regulatory environment within the country to assure accuracy and effectiveness in regulatory submissions, and assess the impact on current/impending submissions.
  • Develop regulatory intelligence network and maximize opportunities to expedite registration processes in the country.
  • Ensure proper filing of and maintenance of local documentation.
  • Archive RA dossiers.
  • Coordinate and execute pharmacovigilance and Field Safety Corrective Action reporting in Vietnam for both marketed products and clinical trials (if any).
  • Provide timely and accurate input to regulatory assessments of products where requested.
  • Review and approval of advertising and promotional material
  • Support sales and marketing colleagues and customers by providing adequate and relevant information.

Yêu Cầu Công Việc

  • Related disciplines
  • Minimum 2-5 years’ experience in the similar role
  • Demonstrate knowledge in regulatory, concepts and methodologies
  • Demonstrate good working knowledge, comprehension and applications of local regulations
  • Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
  • Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
  • Demonstrate fluency in local language and in English, both written and spoken

Thông tin khác

  • Bằng cấp: Đại học
  • Độ tuổi: Không giới hạn tuổi
  • Hình thức: Nhân viên chính thức

Giới thiệu về công ty

DKSH Vietnam Co., Ltd.
DKSH is the leading Market Expansion Services provider with a focus on Asia. The Group helps other companies and brands to grow in the Consumer Goods,...Chi tiết
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