Hybrid Regulatory Operations Associate - Change & Compliance

Pfizer; Makati; Hybrid; PHP 700,000 - 1,000,000; Full time

Job summary

Pfizer seeks a Regulatory Affairs professional in a hybrid role based in Manila. The successful candidate will support post-approval changes, registrations, and renewals while coordinating regulatory documents and liaising with CMOs to ensure timely progression of activities.

The role requires knowledge of US, European and global cGMPs, strong technical writing, and the ability to collaborate in a fast-paced pharmaceutical environment.

Qualifications

• Minimally 2 years of experience in GXP setting and/or Regulatory Affairs role.
• Expertise in Change Management and/or Regulatory.
• Proficient in English and technical writing.

Responsibilities

• Support Post Approval Changes, initial registrations and/or renewals.
• Perform preliminary regulatory impact assessment, facilitate discussions and raise change records in GMP systems.
• Coordinate collection of supporting documents for Post Approval Changes, registrations, BOH queries, and regulatory commitments.
• Act as liaison between CMOs and Pfizer functions to ensure timely progression of change activities.
• Advise regulatory strategy and potential supply constraints within the VSOT as regulatory expert.

Skills

GXP experience

Regulatory affairs

Change management

English writing

Interpersonal skills

Job description

Pfizer seeks a Regulatory Affairs professional in a hybrid role based in Manila. The successful candidate will support post-approval changes, registrations, and renewals while coordinating regulatory documents and liaising with CMOs to ensure timely progression of activities.

The role requires knowledge of US, European and global cGMPs, strong technical writing, and the ability to collaborate in a fast-paced pharmaceutical environment.