HomeFreshersTrainee Executive Regulatory Affairs | Pfizer India | Chennai, India

Trainee Executive Regulatory Affairs | Pfizer India | Chennai, India

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At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer

Position: Trainee Executive Regulatory Affairs

Location: Chennai, Tamil Nadu

Job Description:

Role Summary

  • Delivery 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 changes

Primary Responsibilities

  • Delivery of Product License Support Portfolio
  • Identify opportunities and implement solutions through interaction with other team members, and key contributors across sites, ensuring the 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 in 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 the application of technologies.
  • Demonstrated Project Management Skills: Competent illustration of processes, tools, and techniques for planning and monitoring multiple complex projects to established deadlines.

Qualification: B.Pharma/M.Pharma

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