Regulatory Execution Hub Associate – Hybrid

Pfizer, Inc.; Makati; Hybrid; PHP 600,000 - 1,100,000; Full time

Job summary

Pfizer, Inc. in Makati, Philippines, seeks an IDM RIO Execution Hub Associate/Sr Associate to provide regulatory support to international country and cluster Regulatory teams.

The role spans initial registrations to lifecycle management and product withdrawal, coordinating local M1 documents, HA responses, and regulatory input for launches. The incumbent will collaborate with Country Regulatory Strategists and Hub Submission/Dossier Managers to ensure timely, high-quality submissions, with

Qualifications

• B.S. Pharmacy; equivalent relevant professional experience will be considered.
• Advanced to Fluent English language required. Multilingual skills (i.e. Korean) desirable.
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
• Advanced Microsoft Office Suite skills.
• Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
• An understanding of country/cluster regulatory requirements and trends is preferred.
• Relevant experience within pharma, in Regulatory, quality and/or compliance fields preferred.

Responsibilities

• End-to-end management of multi-regional, regional and national regulatory dossiers for assigned cluster/country/therapeutic area/products, both initial registration applications and ongoing lifecycle management through to product withdrawal.
• Deliver against goals, executing initiatives, implementing new opportunities, and filling gaps related to the production of regulatory International and operational support.
• Identify and escalate quality and compliance issues or emerging risks detected during the management of the Cluster/Country submissions under his/her responsibility.
• Ensure timeliness, quality, compliance, and efficient delivery of critical on-the-job deliverables, bringing efficiencies to the organization.
• In some regions/clusters, the RIO Execution Hub can execute the role of Hub Submission Manager, while in others should closely partner with Hub Submission Manager.

Skills

English fluency

Korean (multilingual)

Software aptitude

MS Office expert

Pharma regulatory knowledge

Regulatory/compliance experience

Education

B.S. Pharmacy

Job description

Pfizer, Inc. in Makati, Philippines, seeks an IDM RIO Execution Hub Associate/Sr Associate to provide regulatory support to international country and cluster Regulatory teams.

The role spans initial registrations to lifecycle management and product withdrawal, coordinating local M1 documents, HA responses, and regulatory input for launches. The incumbent will collaborate with Country Regulatory Strategists and Hub Submission/Dossier Managers to ensure timely, high-quality submissions, with