RIO Execution Hub Associate

23 hours ago

Makati City, National Capital Region, Philippines Pfizer, Inc. Full time $60,000 - $120,000 per year
Use Your Power for Purpose

We're committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will be instrumental in broadening and hastening patient access to Pfizer's medicines and vaccines.

What You Will Achieve

In this role, you will:
  • Act as an approval liaison, providing strategic product direction and interacting with regulatory agencies to expedite pending registrations.
  • Represent regulatory interests to marketing, research teams, and government agencies throughout the product lifecycle.
  • Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports.
  • Ensure compliance with submission standards, procedures, and policies set by Global Regulatory Affairs.
  • Prepare and finalize Global Regulatory Strategy Documents (GRSD) and Comparative Toxicogenomics Database (CTD) sections for Lifecycle Management (LCM) submissions.
  • Provide regulatory support to cross-functional teams, participating in technical reviews, strategic discussions, and approval of promotional materials.
  • Identify and assess regulatory risks, communicate them to the team, and liaise with key stakeholders to ensure filing strategies meet Board of Health (BoH) requirements.
  • Manage continuous improvement of processes related to Human health submissions, maintain regulatory databases, and stay updated on the external regulatory environment and competitor intelligence.
Here Is What You Need (Minimum Requirements):
  • BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience
  • Proven ability to manage complex regulatory or drug development issues
  • Knowledge of the regulations and guidelines in various markets
  • Good skills in communication, collaboration, negotiation, and problem-solving
  • Fluent in English, written and spoken
  • Computer literacy and ability to learn new systems
Bonus Points If You Have (Preferred Requirements):
  • Extensive knowledge of various therapeutic areas
  • Strategic thinking and strong project management skills
  • Strong analytical and critical thinking skills
  • Adaptability in a dynamic regulatory environment
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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