Associate Manager I – Reg CMC Strategy

About this role

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Skills you'll use

What you'll do

• Functions as CMC author/strategist for development and execution of regulatory strategies for theassigned changes which include minor and/or moderate post approval changes/projects/products
• Responsible for end to end PCF assessment
• Authors and compiles response to HA queries within agency timelines
• Projects involving complex CMC changes shall be assigned through mentoring as a part of careerdevelopment, if identified
• Reviews proposed changes for completeness and accuracy and development of initial globalregulatory strategy while considering registered content and seeks endorsement by the CMC GRS.
• Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMCsubmission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMCGRS as appropriate and within agreed timelines.
• Major and Emerging Market focused
• Reviews technical/supportive information for submission to support change
• Reviews and applies pertinent global regulatory guidelines
• Develops technical justification of change for agency submission

Who can apply

• Minimum - Postgraduate in Pharmacy or Science
• Minimum 3 to 7 years of CMC experience within a regulatory function with Knowledge of EU/US and international regulatory practices, policies.
• Proficiency in Microsoft windows, Trackwise, Navigation or similar submission management tools document management systems, publishing tools and operating knowledge of databases.
• Good verbal and written communication skills.
• Motivated, good interpersonal skills, organized, hardworking, agile, adaptable to change and able to meet timelines.
• Team player and ability to work in a highly matrixed environment.
• Customer focus and attention to detail and accuracy is required.
• Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills.
• Willingness to work flexible hours.
• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

About Pfizer

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