Pfizer

Associate, ESOQ Regulatory Operations

Posted 10 Hours Ago

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Makati City, Metro Manila, National Capital Region, PHL

Hybrid

Junior

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

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, investigations, complaints, and GMP change management. Coordinates documentation among contract manufacturing organizations and internal Pfizer teams, advises on regulatory strategy and supply constraints, reviews commercial product complaints, and approves SAP material master workflows. Requires GxP or regulatory experience, knowledge of global cGMP requirements, and strong technical writing and communication skills.

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:

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 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year with Master's degree).
Expertise in Change Management and/or Regulatory.
Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices.
Embraces innovation and change to find solutions.
Collaborative and embraces Pfizer mindset: Courage, Equity, Excellence, Joy.
Proficient in English and technical writing.
Good verbal, written communication, and presentation skills.

Bonus Points If You Have (Preferred Requirements)

Ability to work effectively as a team member within a matrix environment
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
Experience with supplier quality management
Strong interpersonal skills and the ability to work 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 2 years of experience in a GxP setting and/or Regulatory Affairs role, or 1 year with a Master's degree
Expertise in Change Management and/or Regulatory Affairs
Knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, and pharmaceutical quality assurance practices
Proficiency in English and technical writing
Good verbal, written communication, and presentation skills
Ability to work effectively as a team member within a matrix environment
Fundamental understanding of QA and GMP principles and concepts
Experience in pharmaceutical quality assurance or quality control
Knowledge of regulatory requirements and guidelines
Experience with supplier quality management
Strong interpersonal skills and 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, with understanding of responsible AI practices

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.

Learn more about Pfizer's Compensation & Benefits →

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

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.