Business Title Associate II – Reg CMC Strategy, Brands CMC
Job Description
• Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS.
• Global regulatory strategy development in collaboration with the CMC GRS.
• Liaise with Pfizer Global Supply and other support functions as needed.
• Use of regulatory systems and management of CMC documentation and information in support of the CMC GRS.
JOB RESPONSIBILITIES
• Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRS.
•Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMC GRS as appropriate and within agreed timelines.
•Major and Emerging Market focused
•Reviews technical/supportive information for submission to support change
•Reviews and applies pertinent global regulatory guidelines
•Develops technical justification of change for agency submission
•Updates M3 dossier
•Coordinates M3.2.R Ancillary documents
•Flags identified risks to the CMC GRS and/or appropriate leadership
•Represents GRA CMC point of view and meets with key stakeholders to resolve challenges.
•Coordinates internal document review and sign off.
•Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
•Supports Query and/or commitment management in collaboration with CMC GRS.
•Maintains conformance systems maintenance in support of the CMC GRS.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
