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Assistant Manager

3.00 to 5.00 Years   Chennai   08 Apr, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaFinance / Accounts / Tax,Sales / BD
EmploymentTypeFull-time

Job Description

  • Functions as Regulatory support for Biosimilars development projects and the lifecycle changes, works with Global Product Owners (GPOs), cross functional teams, local and regional regulatory colleagues, external partners (in case of in licensed products) and Global Health Authorities (US and Ex-US) to frame and drive global regulatory strategies and Global submissions.
  • Manages the preparation and maintenance of core dossiers for original applications and subsequent changes and coordinates responses to deficiency letters, with the assistance of local and regional regulatory colleagues.
  • Provides adequate support and guidance to the team for authoring regulatory submissions and ensures effective data presentation and quality.
  • Author with team members, key pieces of regulatory submissions on need basis.
  • Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross functional teams and external partners to ensure regulatory data requirement and the deliverable dates are met.
  • Negotiates submission data requirements and deliverable dates with regulatory authorities on need basis.
  • Remains knowledgeable and maintains awareness about current regulations and guidance related to Biosimilars, interprets, assesses its impact on product development programs and communicates to necessary stakeholders.
  • Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management and core team.
  • Responsible for effective coordination and collaboration with the regional regulatory leads to ensures key submission deliverables assigned to the regional group.
  • Responsible for ensuring compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs. Suggests supports and implements system improvements to ensure regulatory compliance, reduce cycle time and create efficiency.
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Keyskills :
salesmisaccountstatbankingequal employment opportunityglobal healthdata presentationregulatory affairsproduct developmentstatements of work sow

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