Hospital Regulatory Affairs

ROLE SUMMARY

Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region).
- 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

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

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.
- Request required documents via internal system, verify and provide to HLM and Phytopharma in a timely manner to serve for Phyto’s commcerical operation.

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

QUALIFICATIONS

Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.
- Ensure effectively communication and collaboration with external stakeholders and relevant Pfizer functions.
- Interact and participate in discussions on tender matters concerning Pfizer’s portfolio/interest and also involve in relationship building with DAV and Industry Associations,as appropriate.
- Monitors, analyzes, interprets and informs line manager regarding legislation/stipulation trends and events including changes in matters such as guidelines, environment issues, regulations, competitor intelligence and external meetings.
- Improve process related to Procurement Process at hospitals/SOH (if needed).
- Participate in and promote Pfizer core values.
- Effectively plan and monitor self-performance to meet set objectives.
- Own self-development, performance management and career planning.
- Be accountable for compliance (of records and systems) within the area of responsibilities
- Complete relevant training activities and comply with relevant standards in the local office to ensure compliance to local, international regulations and Pfizer SOPs.
- Bachelor degree in Science or Pharmacy. At least 2 years of working experience in Registration/Regulation (Tender listings policy knowledge is advantage)
- Fluent in English - written and spoken communication skills. Good knowledge of Pharma Law, Tender Circulars/Law, regulations and practice. Meticulous nature and proficient in data tracking and consolidation.

PHYSICAL/MENTAL REQUIREMENTS
- (not all roles will have physical or mental requirements)_

Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity.

Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis

Normal

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- (not all roles will have non-standard work schedule travel, or environment requirements)_

Include any work schedule, travel or