Regulatory Specialist
3 days ago
**Regulatory Specialist**:
Our team in **South Jakarta** currently has an opening for a **Regulatory Specialist**
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**YOUR ROLE & RESPONSIBILITIES**:
- Develop, ensure and maintain the implementation of the quality management system.
- Focus on managing activities under their authority and maintaining the accuracy and quality of documentation.
- Develop and/or approve basic training programs and advanced training on CDOB for all personnel involved in distribution activities.
- Coordinate and carry out immediately every drug and/or drug withdrawal activity.
- Ensure that customer complaints are handled effectively.
- Qualify and approve suppliers and customers.
- Passing drugs and/or drug materials returned to be returned to the stock of drugs and/or drug ingredients that meet the selling conditions.
- Participate in the making of an agreement between the contract giver and the contract recipient explaining the responsibilities of each party related to the distribution and/or transportation of drugs and/or drug ingredients.
- Ensure that self-inspections are carried out regularly according to the program and that necessary corrective actions are available.
- Delegate their duties to pharmacists/pharmaceutical technical personnel who have obtained approval from the competent authority when they are not in place for a certain period of time and keep documents related to each delegation made.
- Participate in every decision making to quarantine or destroy drugs and/or drug materials that are returned, damaged, recalled or suspected to be fake.
- Ensuring the fulfillment of other requirements required for certain drugs and/or drug ingredients in accordance with the laws and regulations.
**YOUR PROFILE**:
- Minimum Education: Bachelor Degree of Pharmacy and STRA Certification Active min 3 years
- Minimum knowledge : Good Distribution Practice, experience Pharma regulatory for APAC
- Minimum Experience : 2 years
- Other Skills: Computer, fluet in English, must have STRA (Surat Tanda Registrasi Apoteker) Active min 3 years
**OUR OFFER**:
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**INTERESTED?**:
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