Pfizer Senior Regulatory Affairs Specialist in Tamsui, Taiwan
P roduct registration
Participate the development of the registration plans for LE and implement them timely and effectively with the guidance from line manager.
Keep good communication with WSR, regional and NYHQ on Regulatory Affairs issues to ensure the mutual understanding and obtain timely supports.
Cooperate with PGS, WSR, and GCMC to register the new plant through the submission of Plant Master File or Foreign Inspection.
Closely work with Med/MKTG/Logistics to develop new artwork and ensure the success of product launch.
Ensure assigned licenses are renewed in a timely manner
Ensure assigned variations are approved in a timely manner
Ensure responsible Labeling of on-market products are updated in a timely manner and followed Regulation and Pfizer Policy.
Ensure assigned projects of manufacturing/packaging site are approved on agreed timeline and closely communicate with site/Logistics to ensure smooth of supply.
Make sure timely update regulatory information and properly archive regulatory documents.
Clinical Trial A pplication (CTA)
Liaise with clinical research team to seek to understand clinical research program.
In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries.
Coordinate pre-CTA agency consultation meeting.
Be a project/system leader/coordinator to ensure project /system are properly monitored and maintained.
Introduce any new system to relevant colleagues and train RA new members to use existing systems
Support team member for problem shooting coming from systems.
Work with relevant colleagues to develop Work Instruction to streamline the process and obey Pfizer Policy.
Relationship management with stakeholders
Represent the RA role & objectives to both internal & external partners to promote mutual trust and collaborations.
Cooperate with relevant stakeholders to share information & provide a good understanding on RA-related issues.
Attend Association Meeting and get most updated regulatory information.
Complete required trainings and comply with relevant standards to ensure compliance to Pfizer Policy.
Liaise closely with internal stakeholders to ensure on-market products, including labeling, artwork and the finished products, are complied with local regulatory requirements and Pfizer Policy.
Follow necessary approval procedures in updating Labeling as per local regulatory requirements and Pfizer SOP.
Ensure the internal regulatory database is up to date and meet the requirements according to Pfizer SOP.
Training & Education Preferred: Bachelor degree or above, major in pharmacy or other science-related background.
Prior Experience Preferred: Some regulatory related experience
English Skill: TOEIC Score≧650
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.