Pfizer Hiring Freshers for Trainee Executive.
Company Name: Pfizer
Job Role: Trainee Executive
Location: Chennai
Experience: Freshers
Education: B.Sc/M.Sc/B.Pharm/M.Pharm
Apply by: Immediate
Candidates with B.Sc/M.Sc/B.Pharm/M. Pharm can apply for the job role. Good opportunity for the freshers to work as a Trainee Executive at Pfizer.
Key Job Details:
- 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.
- Reviews technical/supportive information for submission to support AR changes
- Manages and reviews stability contributions for accuracy and consistency with commitments
- Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance of Team Lead and CMC GRL as appropriate and within agreed timelines.
Eligibility and Skills:
- 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
- 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
- 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
About Pfizer
Pfizer is a biopharmaceutical company. It provides services in Pharmaceuticals, medicines, health care, and more. The company is headquartered in New York.
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