Pfizer – Regulatory affairs Freshers jobs at Chennai 2021

Pfizer Health care India Pvt Ltd Recruitment Notification details 2021

Department :- Regulatory affairs

Position :- TRAINEE Executive

Location :- Chennai

Job Description :-

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.

Click below link :-—Chennai/Trainee-Executive_4820116?source=linkedin