RIO Execution Hub Sr. Associate

Pfizer


Job Location:

Kuala Lumpur - Malaysia

Monthly Salary: Not Disclosed
Posted on: 19 hours ago
Vacancies: 1 Vacancy

Job Summary

Why Join Pfizer

  • At Pfizer our purpose is Breakthroughs that change patients lives. We pursue this goal relentlessly and innovate every day to make the world a healthier place.
  • Patients are at the center of everything we do and every role at Pfizer contributes to meaningful impact for patients communities and healthcare systems around the world.
  • Our culture is grounded in four core values Courage Excellence Equity and Joy which shape how we work grow and succeed together.
  • Joining Pfizer means being part of a global organization committed to innovation quality compliance and delivering outcomes that matter

Role Summary

  • The EM Asia RIO Execution Hub Senior Associate provides regulatory support to country and/or cluster regulatory teams across the product lifecycle from initial registration through lifecycle management and product withdrawal.
  • This role helps deliver timely high-quality and compliant submissions by preparing and coordinating local regulatory documents and supporting defined regulatory operational activities.
  • The role partners closely with Country Regulatory Strategists and Hub Submission/Dossier Managers to support submission execution dossier quality and sustained compliance

Key Responsibilities

  • Manage/support regulatory activities across assigned (Asia) markets and products.
  • Prepare and review local M1 dossier documents and submission-ready content.
  • Support simple health authority query responses and coordinate on more complex requests.
  • Review dossier build content for assigned submissions.
  • Support regulatory operational activities such as tenders launch planning APQR audit readiness and related compliance support.
  • Escalate quality compliance or emerging risks where needed.

Basic Qualifications

  • Bachelors degree in Pharmacy or Life Sciences or equivalent relevant experience.
  • Experience in Regulatory Affairs within Malaysia or other
  • Advanced to fluent English.
  • Strong technical aptitude and Microsoft Office skills.
  • Ability to work independently solve problems and manage ambiguity.

Preferred Qualifications

  • Experience in pharmaceutical regulatory quality or compliance roles.
  • Familiarity with pharmaceutical systems and organizational structures.
  • Understanding of country/cluster regulatory requirements and trends.
  • Ability to work independently to plan and prioritize deliveries.
  • Multilingual capability is an advantage.

Work Location Assignment:Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.

Regulatory Affairs


Required Experience:

Senior IC

Why Join PfizerAt Pfizer our purpose is Breakthroughs that change patients lives. We pursue this goal relentlessly and innovate every day to make the world a healthier place.Patients are at the center of everything we do and every role at Pfizer contributes to meaningful impact for patients communit...

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