Company Name: PT Tawada Healthcare
Location: Jakarta Barat
Posted Date: 03/10/2024 12:34
Salary:
Job Description
Responsibility:
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- · Responsible for providing regulatory strategies under the direction of the head of division.
- · Support teams to obtain worldwide regulatory approval or clearance for company molecular products and develop global regulatory strategies for new and modified products.
- · Participate in and provide input to project to assure that product registrations and licensing applications (original submission and subsequent product enhancements) meet regulatory requirements.
- · Maintain technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings. Interpret new or existing regulatory requirements procedure.
- · Review and advise on labelling, product claims, marketing brochures, and other publications to ensure compliance with regulations. Comply with applicable Corporate and Divisional Policies and procedures.
Requirement:
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- · Bachelor degree in Pharmacy and have STRA (active)
- · Regulatory Knowledge of (as applicable)
- · At least 1 years relevant experience in industry or distribution medical device company within the regulatory affairs discipline
- · Knowledge of Indonesia medical device regulatory requirements
- · Experience in registration all categorize medical device in MoH and other license in related ministries
- · Excellent verbal and written English communication skills.
- · Computer literate with prior database processing experience.
- · Extraordinary organizational skills.