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:
Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.
Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.
Develop an overall perspective of registration projects.
Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.
Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.
Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and PPG SOPs
Maintain an up to date knowledge of the relevant legislation in China.
Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
Provide regulatory advice to company personnel as required.
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 practicesII. 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 changeIII. Special Projects
Be required to participate on special projects for the Regulatory Affairs GroupIV. Market Support
Attend Regulatory Affairs, Medical Department and other internal meetings as required.
Provide a resource for other sections of the company for specified therapeutic areas.V. Personal Development
Complete related Training.
Attend and actively participate in personal development courses as required.
Attend training in specific therapeutic areas as required.
Participate in Regulatory Affairs and Medical Department projects and workshops
Tertiary qualifications in pharmacy or a science degree with a pharmacology major.
At least 6 years experience in regulatory affairs working.
Good working knowledge of international and local regulatory guidelines and codes
Proficiency in Basic Microsoft Word, PowerPoint and Excel
Organizing and planning
Communication and interpersonal skill
Good sense in the area
Cultural Competencies (Leader Behaviors)
Sustain Focus on Performance
Create an Inclusive Environment
Encourage Open Discussion and Debate
Align Across Pfizer