Be an Early Applicant
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Supports pharmaceutical regulatory operations, including post-approval changes, registrations, renewals, regulatory impact assessments, dossier compliance, and regulatory commitments. Coordinates documentation with contract manufacturers and internal teams, advises on regulatory strategy, supports investigations, manages commercial product complaints, and reviews SAP material master workflows. The role requires expertise in GxP, GMP, quality systems, regulatory requirements, change management, and pharmaceutical quality assurance.
Summary Generated by Built In
Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, grounded in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are vital and will have a direct impact on patients. Your efforts will ensure that our products meet the highest standards of quality and safety, directly impacting the well-being of patients worldwide.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: Hybrid
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 .
Quality Assurance and Control
#BI-Hybrid
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, grounded in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are vital and will have a direct impact on patients. Your efforts will ensure that our products meet the highest standards of quality and safety, directly impacting the well-being of patients worldwide.
What You Will Achieve
In this role, you will:
- Support Post Approval Changes, initial registrations and/or renewals.
- Perform preliminary regulatory impact assessment, facilitate discussions and raise the change management records in the relevant GMP system/s.
- Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, Board of Health (BOH) queries, and regulatory commitments.
- Act as a liaison between CMOs and internal Pfizer functions to ensure timely progression of change activities.
- Act as a regulatory expert within the Virtual Site Operating Team (VSOT), advising of regulatory strategy and potential supply constraints if applicable.
- Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required.
- Actively contribute to support investigations into regulatory discrepancies and any other relevant support as needed for the role.
- Manage complaints for commercial Drug Product and Medical Device and Combination Product, ensuring that investigation reports are appropriate and acceptable as per Pfizer's requirement.
- Review and approve SAP material master workflow tasks for completeness and correctness across enterprise and plant-level data.
Here Is What You Need (Minimum Requirements)
- Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Master's degree).
- Expertise in Change Management and/or Regulatory.
- Experience with relevant QTS and eQMS modules.
- Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices.
- Fundamental understanding of the principles and concepts of QA and GMP
- Experience in quality assurance or quality control within the pharmaceutical industry
- Knowledge of regulatory requirements and guidelines
- Is diplomatic, clear & succint in communication.
- Committed to Change Management best practices.
- Embraces innovation and change to find solutions.
- Collaborative and embraces Pfizer mindset: Courage, Equity, Excellence, Joy.
- Proficient in English and technical writing.
- Good interpersonal and influential skills.
- Good verbal, written communication, and presentation skills.
- Demonstrated success in leading projects.
- Decision making based on science and risk based approach.
- Ability to work with minimal supervision in a global organization.
Bonus Points If You Have (Preferred Requirements)
- Ability to work effectively as a team member within a matrix environment
- Experience with supplier quality management
- Strong interpersonal skills and the ability towork collaboratively with cross-functional teams
- Ability to adapt to changing priorities and work in a fast-paced environment
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: Hybrid
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 .
Quality Assurance and Control
#BI-Hybrid
Skills Required
- At least 5 years of experience in a GxP setting and/or Regulatory Affairs role, or 3 years with a master's degree
- Expertise in change management and/or regulatory affairs
- Experience with relevant QTS and eQMS modules
- Knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, and industry quality assurance practices
- Fundamental understanding of quality assurance and GMP principles
- Experience in pharmaceutical quality assurance or quality control
- Knowledge of regulatory requirements and guidelines
- Clear, concise, diplomatic communication skills
- Commitment to change management best practices
- Proficiency in English and technical writing
- Good interpersonal, influential, verbal, written, and presentation skills
- Demonstrated success leading projects
- Science- and risk-based decision-making ability
- Ability to work with minimal supervision in a global organization
- Ability to work effectively in a matrix environment
- Experience with supplier quality management
- Ability to collaborate with cross-functional teams
- Ability to adapt to changing priorities and work in a fast-paced environment
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, including responsible AI practices
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Pfizer Compensation & Benefits Highlights
-
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.
-
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.
-
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.
Pfizer Insights
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
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.
Gallery
Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
Hudson Yards
Provincia de Buenos Aires
Andover, MA
Athens, GR
Chennai, IN
Collegeville, PA
Durham, NC
Groton, CT
Madison, NJ
Madrid, ES
Mumbai, Maharashtra
Rochester, MI
San Diego, CA
Seattle, WA
Tampa, FL
Center for Digital Innovation
Learn more
