PFIZER Hiring Associate I – Reg CMC Strategy, Brands CMC Apply Now
PFIZER Hiring Associate I – Reg CMC Strategy, Brands CMC Apply Now
- 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.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
Work Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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