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Takeda

Regulatory Affairs Head Colombia

📍 Location
Bogotá, Bogota
⏰ Job Type
Full time
📅 Posted
June 15, 2026

Job Description

Description

The Regulatory Affairs Head manages the process for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general products life cycle management including pro-brand strategies.

Also, is responsible for develop submission strategies; provide guidance/advice on local country regulatory environments; provide assessment of the impact of new and changing regulations/requirements. Keep strong relationship with key external stakeholders such as BoH and industry associations.

  • Evaluate local business and regulatory registration requirements for investigational and marketed products, prepare regulatory assessment reports.
  • Develop submission strategies; prepare project plans, timeslines and related project fees. Prepare project status reports for management/departments.
  • Prepare and submit investigational applications, marke...

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