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The Role
Supports global pharmaceutical regulatory CMC activities for license renewals and annual reports. Authors and compiles CMC dossier contributions, reviews post-approval changes and stability information, applies regulatory guidelines, develops technical justifications, coordinates document reviews, manages commitments and queries, and updates submission components. Collaborates with global regulatory strategists, manufacturing, supply, and cross-functional teams while monitoring timelines, risks, compliance, and submission accuracy.
Summary Generated by Built In
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:
Annual Report (AR) CMC Responsibilities:
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.
Minimum - Undergraduate/Postgraduate in Pharmacy or Science
Minimum 2 - 4 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Regulatory Affairs
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Regulatory Affairs
Skills Required
- Undergraduate or postgraduate degree in Pharmacy or Science
- Two to four years of experience in Regulatory Affairs within a pharmaceutical organization
- Knowledge of regulatory requirements for post-approval changes in global markets
- Knowledge of retrieving information from company and regulatory agency databases
- Basic knowledge of pharmaceutical manufacturing standards, processes, and policies
- Excellent oral and written English communication skills
- Conceptual, analytical, problem-solving, organizational, reasoning, and attention-to-detail skills
What the Team is Saying
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Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, and robust mental‑health benefits, with eligible Pfizer medications available at no cost in U.S. plans. Family‑building support and transgender‑inclusive care are explicitly included, alongside wellbeing resources such as a reimbursement wallet and telehealth options.
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Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional Retirement Savings Contribution, complemented by company‑subsidized life, short‑term disability, and long‑term disability insurance. Materials also reference subsidized retiree medical coverage for eligible groups.
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Leave & Time Off Breadth — Paid vacation, holidays, personal days, and paid parental and caregiver leave are consistently highlighted in current U.S. summaries and job postings. Options like buying extra vacation days and transition‑back support strengthen the time‑off offering.
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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