Associate I

2 days ago

Visakhapatnam, India Pfizer Full time

Functions as a CMC author & strategist supporting CMC Product Leads 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.

Works under the supervision of assigned CMC product lead and is responsible for the assigned CMC activities including authoring of CTD sections (Module 3 and QOS), 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 etc.

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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