Dược Phẩm Sang

- REPORTS TO: T&C Lead
- DEPARTMENT NAME: Tender & Contract Team under Commercial Department

***JOB SUMMARY:
• Tender Regulatory Manager is responsible in monitoring tender related regulatory environment, developing strategic plan of actions (whether advantages/disadvantages) where impacting to tender business, engaging key external stakeholders (Quality-Registration department, Pharma Group Tender workstream but not limited), and shaping tender related policy to ensure the access of Pfizer medicines and vaccine to tendering channel.

• The activities encompass identification of the requirements and submissions to the authorities for GMP evaluation of manufacturing sites for all licensed products, including but not limited to first time filling, supplement, amendment & maintenance of GMP in the list announced by Both; IPP registration for all branded products, including but not limited to filling, supplement, amendment & maintenance of IPP in the list announced by BoH; and any other listing/change updating application that required by BoH for Tender purpose.

• Tender Regulatory Manager provides insights and expertise to guide commercial and regulatory colleagues regarding tender related listing required document/information in registration dossier to ensure alignment of product registered information and tender related requirement to minimize risks for tender of new registration/ post license approval. Sharing updated regulations (Law/Decree/Circulars, including but not limited registration or tender regulation), and provide impact assessment (may directly or indirectly to tender environment) as well as solutions to minimize the risks impacted by regulatory/tender updates.

***JOB RESPONSIBILITIES :
• Monitoring/Screening Tender related Regulatory Environment and Developing Tender oriented Regulatory solutions
o Monitors, analyzes, interprets, and informs regulatory insights to Tender & Contract Team (T&C) and Regulatory Affair (RA) team regarding legislation/stipulation trends and events including changes in matters such as guidelines, environment issues, regulations, competitor intelligence and external meetings concerning Tender matters.
o Co-develop Tender related RA strategy in collaboration with T&C lead and RA to ensure access of Pfizer medicines and vaccines through national and hospital tender system based on Tender Risk Analysis/Assessment due to CMC/PLENC/Other changes.
o Periodically, provides Tender related RA environment monitoring report with recommendation/consultation to T&C Strategy Lead and internal relevant stakeholders (Regulatory, Cat. Lead/CBM…).

• Strategic External Stakeholder Management and Shaping Tender related Policy.
o Establish and enhances partnership with appropriate/relevant stakeholders (in scope) in Drug Administration in Vietnam (DAV) and relevant industry associations (ex., Pharma group) to share information/knowledge and help to shape a better position environment for Pfizer regarding regulatory elements which impacts to tendering activities of products and vice versa (ex., GMP listing, IPP listing and other required listings)
o Interact and participate in discussions on tender matters concerning Pfizer’s portfolio/interest and play as main contact point working with BoH/DAV for any clarifications relating to tender matters with support from assigned Regulatory Affairs Colleague
• Manage tender documents’ validity and provide strategic response.
o Define the list of required documents using for Tender of each product and which of those documents need to maintain the validity/accuracy working with T&C Strategy Lead
o Review the required documents to ensure the quality, consistent and scientific integrity across the Tender-related documents submitted to DAV.
o Manage Tender related regulatory documents for maintaining and tracking for tender requirement’s documents effective ways (with support from responsible regulatory colleagues and T&C Support team) for new launch & licensed products which align with Tender process.
o Responsible for preparation, submission and approval, following-up timeline/strategy to maintain validity of documents including but not limited to, GMP listing, IPP listing, and any other listing application that required by Tender Circular/Law for Tender purpose (excluding MA, PI/AW and registration matters which are managed by responsible regulatory colleagues).
o Review, analyze and provide feedback to T&C Strategy Lead to handle queries from Customer (ie: Hospital, SoH…) related to provided documents/listings & product information as required in a timely manner during pre-in-post tender.

• Compliance
o Be accountable for compliance (of records and systems) within the area of responsibilities.
• Tender Regulatory Manager may be responsible for other relevant Tender related strategic project and tasks as assigned by T&C Strategy Lead/Commercial Lead/company where required.