Senior Associate, ESOQ Regulatory Operations

About the role

Pfizer is hiring a Senior Associate for its ESOQ Regulatory Operations team. The role supports post-approval changes, registrations and renewals, acts as a regulatory expert within the Virtual Site Operating Team (VSOT), and covers dossier compliance, regulatory investigations and complaint management. It is a hybrid position.

Key responsibilities

• Support post-approval changes, initial registrations and renewals, including preliminary regulatory impact assessments and raising change management records in the GMP systems.
• Coordinate supporting documents for post-approval changes, registrations, renewals, Board of Health queries and regulatory commitments.
• Act as liaison between CMOs and internal Pfizer functions to keep change activities progressing on time.
• Advise on regulatory strategy and potential supply constraints within the VSOT.
• Support dossier compliance assessment and the implementation of new regulations and compendia requirements.
• Contribute to investigations of regulatory discrepancies and other regulatory support.
• Manage complaints for commercial drug products, medical devices and combination products, ensuring investigation reports meet Pfizer's requirements.
• Review and approve SAP material master workflow tasks for completeness and correctness across enterprise and plant-level data.

Required profile

• At least 5 years of experience in a GXP setting and/or regulatory affairs role, or 3 years with a Master's degree.
• Diplomatic, clear and succinct communicator; collaborative and able to work with minimal supervision in a global organisation.
• Proficient in English and technical writing, with good verbal, written and presentation skills.
• Proven success in leading projects and a decision-making approach based on science and risk.

Required skills

• Change management and/or regulatory expertise.
• Experience with QTS and eQMS modules.
• Knowledge of US, European and global cGMP, compliance issues, inspectional trends and QA/GMP principles.
• Quality assurance or quality control experience in the pharmaceutical industry.
• Knowledge of regulatory requirements and guidelines.
• Preferred: matrix team environment, supplier quality management, adaptability to fast pace, and familiarity with AI tools such as ChatGPT or Microsoft Copilot.