Associate, ESOQ Regulatory Operations

Pfizer Inc; Makati; Híbrido; PHP 640.000 - 980.000; Jornada completa

Descripción de la vacante

Pfizer Inc. in Makati City, Philippines, is seeking an Associate for ESOQ Regulatory Operations. The role is full-time with a hybrid work location.

You will support post-approval changes, registrations, and regulatory commitments, coordinating with CMOs and internal Pfizer teams to ensure timely progress and regulatory compliance. Qualified candidates have 2+ years in GXP or regulatory affairs, strong English writing and communication skills, and experience with global cGMPs.

Formación

• Minimally 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.
• Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends.
• Proficient in English and technical writing.
• Good verbal, written communication and presentation skills.

Responsabilidades

• Support Post Approval Changes, initial registrations and renewals.
• Coordinate collection of supporting documents for changes, BOH queries, and regulatory commitments.
• Act as liaison between CMOs and Pfizer functions to ensure timely progress of changes.
• Advise regulatory strategy within the VSOT and assess supply constraints if applicable.
• Support dossier compliance assessment and new regulations/compendia implementation.
• Investigate regulatory discrepancies and provide needed support.

Conocimientos

GXP

Regulatory affairs

Change management

Technical writing

Cross-functional

English proficiency

Communication skills

Presentation skills

Teamwork

Descripción del empleo

Associate, ESOQ Regulatory Operations### Associate, ESOQ Regulatory Operations申请: Philippines - Makati City: 全职: 今天发布: 4967594**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 useWork Location Assignment: Hybrid Work Location Assignment: Hybrid 辉瑞是平等机会的雇主,并且在其运营的每一个司法管辖区遵守所有适用的平等就业机会立法。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.