Use Your Power for Purpose
We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.
JOB SUMMARY
Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
Keep close working relationship with HA officials and KOLs.
Interact with other functional team closely.
Ensure optimal regulatory compliance in China.
JOB RESPONSIBILITIES
Collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:
Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
Closely follow up submission, QC testing, evaluation and approval in CNDA, CDE and official labs.
Keep communication with HQ and other internal functional teams.
Keep alert on regulatory intelligence.
Develop and improve good working relationship with HA and KOLs.
Report to line management regularly.
Maintain and update the Local Product Document (labeling) and Artworks in accordance with relevant regulations and Pfizer SOPs.
Partner with the global regulatory and clinical development team in china PBG BUs for new products development strategy and inline products strategy.
Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
Partner with PGS for supply strategy to avoid supply issue due to site changes.
Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
Ensuring Regulatory Compliance.
Ensure timely communicate the requirement of CHP and other China regulations to PGS QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites.
Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and specification/manufacture process change.
QUALIFICATIONS / SKILLS
Education
A bachelor degree major in chemistry, pharmaceutics, biology, medical or a related life- science discipline, or equivalent. A master degree or above is preferable.
Experience
At least 2 years drug registration experience in pharmaceutical companies.
Technical
Knowledge of drug development process, laws, regulations and practices affecting the pharmaceutical industry
Project management skill
Good skills on communication, collaboration, negotiation and problem solving.
Good English skill in both spoken and written.
Good computer skill.
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs#LI-PFE