Regulatory Affairs Officer

Job Description

1.Regulatory Affairs

This position will mainly focus on assiting Head of Regulatory & Public Affairs in handling all regulatory affairs matters in collaboration with other departments and other personnel involved, such as:

-Implementing the registration strategy set out by Head Office (HO) and assist in developing this strategy through communication of all relevant information to HO (such as: local regulatory requirements, regulatory timelines, etc.)

-Contacts with the Competent Authorities/CA (such as Indonesian FDA, Ministry of Health, etc.), in particular for any registration requirements should be clarify with Indonesia FDA, in coordination with HO team, if necessary.

-Identifying all elements and actions necessary for obtaining and mai_ntaining valid marketing authorizations (MA) in the local market.

-Identifying all activities that should be impacted by a change brought to MA (SmPC, PIL, promotional materials, etc.).

-Submitting all regulatory documentation (new submission, renewal, all variation, etc.) to the CA based on the regulation.

-Ensuring the compliance of all activities, including the update of packaging items, medical information, Post-Authorization safety studies in accordance with regulation.

-Archiving all official correspondences with CA.

-Coordinating implementation of Risk Minimization Measures (such as dispatch of DHPC or educational material, prepared by HO), ad ensuring the traceability and archiving of these measures.

2.Responsible Pharmacist for Pharmaceutical Wholesaler of Finished Product

This position will act as a Responsible Pharmacist related to finish product. The activities are mainly in coordination with Head of Regulatory & Public Affairs, that include:

-Develop, ensure, and maintain the implementation of Quality Management System.-

-Control in handling-in and handling-out the drug products stored in the warehouse.

-Ensure the accuracy and quality of the documentation.

-Develop and/or approve the basic and continuous training program regarding Good Distribution Practice for all personnel involved in distribution activity.

-Coordinate every recall activity.

-Make sure that every product complaint has been managed effectively.

-Conduct the qualification and approval on every supplier and customer.

-Involved in the preparation of contract agreement, which explain the responsibility of each party in activity related to distribution and/or transportation of drug product.

-Make sure that self inspection has been conducted regularly.

-Involved in every decision making process to quarantine and/or destroy a returned, broken, recall, and/or suspected falsified product.

3.Pharmacovigilance Activities

-Act as a Local Pharmacovigilance (LPV) back-up in case of LPV and Deputy LPV absence and the Job Description (JD) of LPV applies. 

Candidate Profile