Regulatory Operations Associate — Global Compliance & Change

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

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.