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Associate Manager I - Reg CMC Strategy, Brands CMC

4.00 to 6.00 Years   Chennai   07 Mar, 2022
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Functions as a GCMC Strategist for Brands CMC - License Renewals Team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams (RRHS/PCO/RCM/Site CNM) to prepare and submits the CMC contributions Renewal applications for global markets as per defined timelines.Job Responsibilities:Individual Contributor responsible for own work (requiring periodic review) under general supervision:Has strong knowledge/understanding of the principles and concepts of the process being followed, to perform the below listed activities but not limited to :
    • Preparation of the CMC contributions for Renewal applications for the assigned products for global markets
    • Liaise with Pfizer Global Supply and other support functions as needed.
    • Use of regulatory systems and management of CMC documentation and information in support of the GRS-CMC/RRHS.
    • Manages the day to day work activities associated with assigned renewal applications within agreed upon timelines.
    • Reviews and applies pertinent regulatory guidelines for authoring renewals
    • Develops initial renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC/RRHS.
    • Authors and/or compiles CMC contributions for renewals, i.e. Module 1, M2.3.S/P, M3.2.S/P/R/A under guidance from the GRS-CMC/RRHS as appropriate and within agreed timelines.
    • Reviews technical/supportive information for submission to support renewals
    • Develops technical justification of change for agency submission as needed
    • Updates impacted dossier components as needed
    • Coordinates M1/M3.2.R Ancillary documents as needed
    • Makes decisions to resolve minor problems in standard situations as per the guidance and policies and escalates complex problems / identified risks to the GRS-CMC/RRHS and/or appropriate leadership
    • Coordinates internal document review and sign off.
    • Utilizes Pfizer s systems, i.e. PEARL, GDMS, PDM, SPA, etc, to develop expertise & may start guiding/mentoring other colleagues within Renewals/across brands teams.
    • Supports Query and/or commitment management in collaboration with GRS-CMC.
    • Ensure compliance to assigned P2L and Pfizer compliance trainings for self.
    Preferred Education:Minimum Postgraduate in Pharmacy / SciencePreferred Experience:Minimum 4-6 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical OrganizationPreferred Attributes:Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.Technical Skills:
    • Regulatory requirements of post approval changes for global market.
    • Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals.
    • Knowledge in retrieving information from company s and regulatory agency databases.
    • Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
    ,

Keyskills :
salesmanagementmiscustomer relationsqualityequal employment opportunitycontinuous improvement facilitationproblem solving

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