Sobre este puesto de Associate II - Reg CMC Strategy en Pfizer
JOB SUMMARY
Provides functional support to the Brands CMC Strategist for the License Renewals and Annual Reports team, working closely with the CMC Global Regulatory Strategist – CMC (GRS‑CMC) and cross‑functional teams (RRHS/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.
JOB RESPONSIBILITIES
Manages day-to-day regulatory activities associated with assigned Renewals and Annual Reports within agreed upon timelines under the guidance of Team Lead / designee.
Renewals CMC Responsibilities:
Demonstrates Fundamental Knowledge of Process Principles and Concepts; Activities Include, but Are Not Limited to:
- Provides support to Renewal Strategists in the preparation of CMC contributions for renewal applications for assigned products across global markets.
- Authors and/or compiles CMC contributions for renewals, including Modules 1, 2.3.S/P, and 3.2.S/P/R/A; collaborates with GRS‑CMC and RRHS, as appropriate, and within agreed timelines.
- Liaises with Pfizer Global Supply and other support functions, as needed.
- Applies relevant regulatory guidelines in the authoring of renewal documentation.
- Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‑CMC and/or RRHS; supports query and/or commitment management in collaboration with GRS‑CMC.
- Reviews technical and supporting information for submission to support renewal applications.
- Updates impacted dossier components, as required; escalates timeline delays and supports risk identification and mitigation in collaboration with the Team Lead (TL) or designee; flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates Module 1 and Module 3.2.R ancillary documents, as needed.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.
Annual Report (AR) CMC Responsibilities:
- Reviews changes implemented during the reporting period for completeness and accuracy; develops the initial Annual Report regulatory strategy while considering registered content and seeks endorsement from the CMC GRL.
- Authors and/or compiles CMC contributions based on changes made during the applicable reporting period (e.g., Modules 1 and 3), under the guidance of the CMC GRL, within agreed timelines.
- Reviews all relevant systems to confirm post‑approval changes submitted and approved, including commitments made and fulfilled.
- Reviews technical and supporting information for submission to support Annual Report changes.
- Manages and reviews stability contributions to ensure accuracy and consistency with approved commitments.
- Reviews and applies relevant U.S. regulatory guidelines to confirm appropriate Annual Reportable filing classifications.
- Develops technical justifications for changes for agency submission, as needed.
- Updates impacted dossier components, as required.
- Coordinates Module 3.2.R ancillary documents, as needed.
- Escalates timeline delays and flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer CMC systems (e.g., GDMS, PDM, SPA), as appropriate.
- Ensures compliance with Pfizer internal procedures and training SOPs (PLA).
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Preferred Education:
Minimum – Undergraduate/Postgraduate in Pharmacy or Science
- Preferred Experience:
Minimum 2 - 4 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
- Preferred Attributes:
Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.
- Technical Skills:
- Knowledge on Regulatory requirements of post approval changes for global market.
- 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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Regulatory Affairs
