Regulatory Operations Associate - Hybrid & Compliance

Pfizer; Makati; Ibrido; PHP 550.000 - 900.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work

Descrizione del lavoro

Pfizer in Manila (Hybrid) is seeking a Regulatory Affairs professional to support post-approval changes, registrations, and renewals. You will coordinate regulatory documentation, liaise with CMOs, and advise on regulatory strategy within the VSOT, ensuring timely progress and adherence to global cGMP standards.

The role requires 2+ years in GXP/Reg affairs, strong English writing, and collaboration within a matrix environment.

Competenze

• 2+ years 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 QA practices.
• Proficient in English and technical writing.

Mansioni

• 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, 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 VSOT, advising on regulatory strategy and potential supply constraints if applicable.
• Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required.
• Actively contribute to investigations into regulatory discrepancies and other relevant support for the role.
• Manage complaints for commercial Drug Product and Medical Device and Combination Product, ensuring investigation reports meet Pfizer’s requirements.
• Review and approve SAP material master workflow tasks for completeness and correctness across data.

Conoscenze

Regulatory affairs

Change management

cGMP knowledge

English writing

Descrizione del lavoro

Pfizer in Manila (Hybrid) is seeking a Regulatory Affairs professional to support post-approval changes, registrations, and renewals. You will coordinate regulatory documentation, liaise with CMOs, and advise on regulatory strategy within the VSOT, ensuring timely progress and adherence to global cGMP standards.

The role requires 2+ years in GXP/Reg affairs, strong English writing, and collaboration within a matrix environment.