Applications are invited from eligible candidates for the post of Trainee Executive at Pfizer, Chennai.
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The name of the company commemorates its co-founder, Charles Pfizer.
- Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines under the Team Lead guidance and supervision.
- Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
- Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from Team Lead and CMC GRL as appropriate and within agreed timelines.
- Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled
- Reviews technical/supportive information for submission to support AR changes
- Manages and reviews stability contributions for accuracy and consistency with commitments
- Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
- Develops technical justification of change for agency submission as needed
- Updates impacted dossier components as needed
- Coordinates M3.2.R Ancillary documents as needed
- Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership
- Coordinates internal document review and sign off
How to Apply?
Interested applicants can apply for the post through this link.
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