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Senior Regulatory Sciences Specialist

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Pfizer

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Location:
Taiwan , Taipei

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Senior Regulatory Sciences Specialist is responsible for end-to-end regulatory strategic activities of product registration life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs).

Job Responsibility:

  • Provide strategic product direction and interact with regulatory agencies to expedite approval of pending registrations
  • Represent regulatory interests to marketing, research project teams, and government agencies throughout the product lifecycle
  • Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
  • Provide input to stakeholders for product development in line with business objectives, ensuring strategies are reflected in country plans and aligned with regulatory activities and commercial goals
  • Support the development of Regulatory Affairs by maintaining internal databases, tracking systems, and document management, and offering regulatory inputs for promotional material approval
  • Oversee clinical trial applications, manage queries and commitments with stakeholders, and ensure manufacturing and packaging projects are approved on time, maintaining licenses in compliance with local regulations
  • Participate the development of the registration plans for NDA, LE and PMF and implement them timely and effectively with the guidance from line manager
  • Partner with cross-functional teams for readiness of the change implementation
  • Ensure the assigned products and GMPs are maintained in full compliance with local regulations and company SOPs
  • Ensure key changes of the assigned products are closely communicated with relevant internal stakeholders to ensure readiness of change implementation
  • Represent the Regulatory role & objectives to both internal & external partners to promote mutual trust and collaborations
  • Cooperate with relevant stakeholders to share information & provide a good understanding on progress, risk or issues of Regulatory-related activities
  • Attend Association Meetings and get most updated regulatory information
  • Complete required trainings and comply with relevant standards to ensure compliance to Pfizer Policy and SOPs

Requirements:

  • Bachelor degree or above, major in pharmacy or other science-related background
  • 2-3 years regulatory related experience
  • TOEIC Score≧650
  • Professional expertise in local pharmaceutical regulations
  • Good communication skill
  • Problem solving
  • Project Management
  • Teamwork
  • Strategic thinking
  • Negotiation

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
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