Associate II
1 month ago
Responsibility:
Functions as Support to Product Lead for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections for post approval submission. Responsible for effective coordination with the cross functional teams, site and Global RA teams for review. Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (Batch records, Exhibit batch and stability protocol). Provides regulatory assessment and support the Change Control Assessment with minimal guidance. To ensure commitments (module 2-5) made to Health Authorities are entered into tracking systems and are fulfilled to closure, as appropriate. Participate and provide inputs in technical reviews and Change Control reviews as assigned. Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Remains updated about current regulations and guidance interprets and implements in the assigned projects. Responsible for ensuring compliance to organization submission standards, policies and procedures.Qualification :
Preferred Education:Bachelors or Master in Science / Pharmacy
Preferred Experience:Minimum 4-6 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling new submissions / post approval changes to health authorities especially of US and EU. Experience in filing Sterile Injectables submission is preferable.
Preferred Attributes :Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Well-organized and accustomed to maintaining excellent records.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs-
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