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Executive

1.00 to 3.00 Years   Chennai   02 Dec, 2020
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

ROLE SUMMARYDelivery of electronic and paper regulatory transactions in support of New Product Launches, Legalizations, and License maintenance (eg, COPP , GMP , FSC certifications etc)Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities (e.g. legalizations)Subject matter expert of Pfizer s positions in support of proposed changesPrimary Responsibilities

  • Delivery of Product License Support Portfolio
  • Identify opportunities and implement solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
  • Knowledge share and educate personnel as appropriate on agency requirements and guidelines.
  • Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.
  • Process development and change management in the context of PLS submissions
  • Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution
  • Utilization support of electronic technologies for submissions and tracking of documentation
  • Matrix management of cross-functional teams as appropriate
  • Development and maintenance of documented procedures and guidelines as necessaryPrimary Responsibilities
  • Delivery of Product License Support Portfolio
  • Identify opportunities and implement solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
  • Knowledge share and educate personnel as appropriate on agency requirements and guidelines.
  • Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.
  • Process development and change management in the context of PLS submissions
  • Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution
  • Utilization support of electronic technologies for submissions and tracking of documentation
  • Matrix management of cross-functional teams as appropriate
  • Development and maintenance of documented procedures and guidelines as necessary.
Technology Expertise:
  • Technology: Experience and competency with Regulatory software, Document Management, regulatory milestone reporting tools.
  • Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines
  • Demonstrated fluency with regulatory submissions and understanding of application of technologies.
Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs,

Keyskills :
change managementregulatory affairsdocument managementlegislative relationsregulatory submissionsgmpsoftwareplanninglaunchesreportingmanagementcomplianceregulatorymonitoring

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