Hospital Regulatory Affairs (Hanoi)

Chi tiết
* Hospital Regulatory Specialist is responsible to support the regulatory elements/documents which are required by Phytopharma to fulfill the requirements from BOH in procurement process at hospitals. The activities encompass 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 BoH; 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 application that required by BoH.
* Hospital Regulatory Specialist is expected to support product commercialization by ensuring that internal required documents are provided to Phyto for their commercial activities in a timely and correctly manner.
* Engagement with BOH/DAV will be necessary to understand requirements/ queries/ concerns, align on specifics and accelerate postivie outcomes.
* Hospital Regulatory Specialist may be responsible for other relevant tasks as assigned by MA Lead as needed.
ROLE RESPONSIBILITIES
Manage documents' validity required by hospitals (valid time and consistency)
* Working with Hospital Liaison manager (HLM) to define the list of regulatory documents of each product are required by BOH for Phytopharma's commcerial activities at hospitals and which of those documents need to maintain the validity/accuracy.
* Working within HLM and RS team to build tracking plan for required documents (with support from responsible regulatory colleagues) for new launch & licensed products which align with business strategy. Get endorsement/approval from MA lead.
* Provide document review in order to ensure the quality, consistent and scientific integrity in related documents submitted to DAV.
* Under guidance and advice from MA lead, also collaborate with RS and Policy partner, This people be responsible for preparation, submission and getting 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 BOH in Phytopharma's commcerial activities at hospitals (excluding MA, PI/AW and registration matters which are managed by responsible regulatory colleagues).
* Request required documents via internal system, verify and provide to HLM and Phytopharma in a timely manner to serve for Phyto's commcerical operation.
* Support the maintenance of the relevant record and relevant Pfizer Systems while ensuring timely updates as governed by the SOP (this is subjected to those documents in scope such as: IPP, GMP, CoA, CPP...).
Contact point to work with BoH for any clarifications of policies/circular relating to hospital's procurement process with support from assigned Regulatory Affairs Colleague.
Support Phytopharma in provide strategic response correctly, timely to Phytopharma for product-related hospital's queries
Provide Business Risk analysis/assessment due to CMC changes
* Monitors and maintains awareness of MA lead and HLM as soon as possible for changes which potentially impacts to Phytopharma's commercial operation at hospitals (changes relating to MA, PI/AW, Product changes will be informed/shared from responsible regulatory colleagues)
* Work as a Policy partner in PG on Procurement WG to input/consultant/capture the policy change in industry. Also align with Policy Partner and RS to work with PG