Associate Registration Manager
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Collaborateand CommunicatewithChinaPBGPresidenton the ways to help the country meet annualobjectivesof different BUs and ensureregulatorysupportsto the marketing and sales effortthrough:
I. Responsibilities
Prepare the regulatory submissions for registration of new products variations to marketedproductsand clinical trial applications where.
Critically analyze data packages for regulatory compliance andidentifydiscrepancies in data presented and requestadditionaldata.
Develop an overall perspectiveofregistration projects.
Prepare responses to deficiency letters and ensure that these and other data requirements aresubmittedto regulatory agencies within the stipulated or agreedtimeframes.
Maintain contact with officials of Chinese regulatory agencies todetermineregulatory requirements ensure compliance with theregulationsandexpediteapprovals.
Maintain and update the Local Product Document (labeling)and Artworkin accordance withrelevant regulations andPfizerSOPs
Maintain anup to dateknowledge of the relevant legislation in China.
Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
Provideregulatory advice to company personnel as.
Partner with the globalregulatoryand clinical development team inChina PBGBUs for new productsdevelopment strategy and inline products strategy.
Partner with PGS and Pharma Sciences for the implementation China GMP ChinesePharmacopeia(CHP) and other Chinaregulatoryrequirements in PGS sites.
Partner with PGS for supply strategy to avoid supply issue due to site changes
Provideregulatory inputsfor the approval of promotional materials following applicableregulatory requirementPfizer policies procedures and practices
II.Ensuring Regulatory Compliance
Ensuretimelycommunicatetherequirement of CHP and other China regulations toPGS QOand GCMC tofacilitatetheimplementof CHP and other regulations in PGS sites
Ensure local process in place for thetimelysubmission of all the quality and safetyrelevantvariations including labeling safety updateandspecification/manufacture process change
III. Special Projects
Betoparticipateon special projects for the RegulatorySciencesGroup
IV. Market Support
Attend RegulatorySciences MedicalDepartmentand other internal meetings as.
Provide a resource for other sections of the company for specified therapeutic areas.
V. Personal Development
Complete the Pfizer PRE Safety Reporting Process: Overview training module in the settimeframe.
CompleterelatedTraining.
Attend and activelyparticipatein personal development courses as.
Attend training in specific therapeutic areas as.
Participate in RegulatorySciencesandMedicalDepartmentprojects and workshops.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsRequired Experience:
Manager
Key Skills
About Company
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