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← Bayer Vietnam Limited (Bvl)

Regulatory Affairs Officer (8 months)

Bayer Vietnam Limited (Bvl) · Hà Nội
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Type
Full-time
Work mode
On-site
Level
Staff
Industry
Other
Salary
Thương lượng
Location
Hà Nội, Hà Nội, Hà Nội

Overview

  • Conducts technical review and assessment, prepares and submits to the regulatory authorities all pertinent documents related to product registration.
  • Secures from Global Regulatory Affairs, other Bayer affiliates & from R&D the required documents and materials needed for ensuring local registrations.
  • Provides regulatory support and guidance to colleagues in their procurement, marketing, sales and manufacturing activities to ensure compliance to relevant internal and external regulations.
  • Assists marketing in development and documentation of product claims, text and promotional materials to comply with HA regulations.
  • Develop and foster personal contact within HA and other pertinent agencies.
  • Conducts competitive intelligence networking of products as necessary. Conducts training on relevant SOPs, Issues and laws, product information as necessary.
  • Attend to queries related to product information.
  • Maintain registration of products intended for local marketing.
  • Coordinates requirements from governmental agencies concerned for product initial registration/renewal and documentation.
  • Fulfills medical and pharmaceutical certification, clearance of reclassification, promotional approval requirements requested by Marketing.
  • Reviews text of local product inserts (PIs), local Artwork in coordination with the internal approvers, consistent with agreed task ownership matrices.
  • Develops objectives and strategies on tasks to ensure implementation and successful achievement of all plans.
  • Formulates together with line manager, individual performance objectives to enhance expertise, technical skills and overall effectiveness.
  • Ensures maintenance and upkeep of all regulatory affairs documents
  • and internal reporting databases.
  • Performs other duties required by line manager from time to time.

Benefits

Training

Summary of facts from the official posting. View original ↗

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