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Associate Ii

2 months ago

Chennai, India Pfizer Full time

Role Summary:
Functions as the CMC author & strategist for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and developing regulatory strategies for global markets including US/EU/APAC/LATAM & AfME regions; Accountable for assigned projects and activities, completing work within assigned product portfolio.

Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements, develops strategies, assess risks and develops contingency proposals. Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.

Works under the supervision of CMC product leads and is responsible for authoring of CTD sections (Module 3 and QOS) and review of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control; Management of Queries.

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

LI-PFE

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