Pfizer Released Job Openings On 26/07/2022. Pfizer Inc. is an American multinational pharmaceutical corporation. Pfizer is one of the world’s largest pharmaceutical companies, and was ranked 64th on the 2020 Fortune 500 list of the largest U.S. corporations by total revenue, at $47.644 billion as of December 31, 2020 .
Vacancy Details:
Pfizer Recruiting Postgraduate in Pharmacy / Science with 12 years of experience For Group Manager – Regulatory CMC Strategy, NP CMC Support Position.Complete Details for the Group Manager – Regulatory CMC Strategy, NP CMC Support as follows.
Important Details :
- Location : Chennai
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 26/07/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- Manages the day to day work activities associated with assigned License Renewals and Annual Reports within agreed upon timelines of the team and self.
- Responsible for the deliverables of the team
- Authors and/or compiles CMC contributions for renewals and annual reports, on needed basis.
Renewals:
- Responsible for assigning the SPA renewal records to the appropriate renewal author within the team.
- Ensures initiation of regulatory requirements confirmation for renewals prior to 4-6 months due to the documents to PCO.
- Provides regulatory guidance to the team members in the matters of renewal applications and annual reports
- Responsible for ensuring timely and quality preparation and/or review of renewal of packages, annual reports and Quality Query Response (QQR), ensuring effective data presentation and quality.
- Responsible for ensuring best practices and learnings from license renewal update meetings are communicated to the renewal authoring team . Also raises questions / points of clarification from the renewal authoring team to the license renewal SME.
- Responsible for reviewing and reporting on all unplanned renewals on a monthly/quarterly/annual basis.
- Works with Pfizer point of contact and takes the lead in negotiating unplanned renewal delivery timelines with the market CRL, especially when notification is made to the renewal team shortly prior to or after the due date to Pfizer Country Office (PCO).
Annual Reports:
- Responsible for ensuring support for annual reports for all applicable markets (US, China, Brazil, Jordan..etc)
- Ensures changes made during the reporting period are reviewed for completeness and accuracy.
- Ensures development of initial annual report regulatory strategy while considering registered content and seeks endorsement by the CMC Lead.
- Ensures support to Query and/or commitment management in collaboration with CMC Lead.
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