Region and/or Country (if applicable) : Not Applicable
Version Date: 31-Oct-2017
Organizational Relationship(s) including to whom the position reports (JD Job Title):
Position reports to Manager, Legacy Brands NDA AR CMC.
Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines.
Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
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 the 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.
Ensures compliance to Pfizer internal procedures and training SOPs (Power 2 Learn).
Technical Skill Requirements
Knowledge on Regulatory requirements of post approval changes for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
Knowledge in retrieving information from company’s and regulatory agency databases.
Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.