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Job Description
PURPOSE OF JOB/POSITION
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.
ACCOUNTABILITIES
- 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, market applications, varations, post approval reporting obligations and general product life cycle management support.
- Provide strategies to management and interact with regulatory agencies to resolve related agency review questions.
- Maintain a centralized archive of all regulatory files.
- Establish a library of all applicable regulations and guidance documents
- Provide guidance/advice on international regulatory environments; provide assessment of the impact of new and changing regulations/requirements.
- Participate and provide international guidance to CMC, preclinical, clinical and marketing program teams as needed.
- Develop strong and
📌 Regulatory Affairs Head Colombia (Bogotá)
🏢 9732 Takeda Colombia S.
📍 Bogotá
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