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Regulatory Operations Associate

1 week ago


Makati City, National Capital Region, Philippines Pfizer, S.A. de C.V Full time

We're a pharmaceutical company in relentless pursuit of breakthroughs that change patients' lives. Our innovation every day makes the world a healthier place.

To realize our purpose, we've established clear expectations for achieving goals and how we'll go about it.

We offer competitive compensation and benefits programs designed to meet diverse needs of our colleagues.

Our team relies on dedicated and agile members who understand the importance and impact of their roles in our mission. Patients need colleagues like you who take pride in work and always look to improve outcomes. You will help ensure patients and physicians have the medicines they need when they need them.

What You Will Achieve

You will be a member of our Quality Assurance and Control team. You will be responsible for developing and maintaining quality programs, processes, and procedures ensuring compliance with established standards and agency guidelines.

You will assess the quality of external suppliers' products, processes, and related documents while ensuring product specifications are met and quality systems are maintained.

You will be known as a team player able to achieve targets on time. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

How You Will Achieve It

  • Support post-approval changes, initial registrations, and/or renewals.
  • Review and assess changes affecting our third-party manufacturing operations by performing regulatory impact assessments in collaboration with regulatory strategists as needed.
  • Liaise between CMOs, Virtual Site Operations Teams (VSOTs), Pfizer Global Supply (PGS) sites within the Global Chemistry, Manufacturing Compliance (CMC) organization, regional strategists (if required), or Pfizer Country Offices (PCO).
  • Initiate Quality Tracking System (QTS) records if identified as change owner, post-approval change (PAC) records, and regulatory change control (PCF) for third-party manufacturing operations or Pfizer-initiated post-approval changes with potential regulatory impact.
  • Coordinate collection of supporting documents for post-approval changes, initial registration, renewals, and BOH queries from third-party manufacturing operations and PGS sites as required.
  • Monitor and notify third-party manufacturing operations and VSOT through the escalation process of regulatory submission status, BOH queries, commitments, and approvals.
  • Act as regulatory expert within VSOT advising on regulatory strategy and potential supply constraints, if applicable.
  • Act as regulatory expert for third-party manufacturing operations liaising with Pfizer Global Regulatory Science (GRS) and supporting systems (e.g., RRM, PEARL, GDMS, etc.).
  • Support compliance assessment and new regulations/compendia requirements implementation as required.
  • Manage routine complaints for commercial drug product and medical device combination product.