Associate Ii Reg Cmc Strategy
Job Description
Role Summary:
Functions as the CMC author & strategist for the Life Cycle Management (LCM) activities of assigned 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 senior authors/strategist/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.
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Job Detail
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Job IdJD3046152
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationChennai, Tamil Nadu, India
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EducationNot mentioned
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ExperienceYear