Associate I-Reg CMC Strategy

• 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).

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 – Postgraduate in Pharmacy / Science

• Preferred Experience:

Minimum 0 - 1 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization.

Excellent oral and written English communication skills.

Good conceptual and reasoning skills.

Attention to details.

• 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:
• 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.

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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