JOB SUMMARY:

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).

What You Will Achieve:

In this role, you will:

• 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.

• JOB RESPONSIBILITIESProduct registration

• NDA, Line Extension (LE) and Plant Master File (PMF)

• 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

• Product life-cycle management

• 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

• Relationship management with stakeholders

• 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

• Regulatory compliance

• Complete required trainings and comply with relevant standards to ensure compliance to Pfizer Policy and SOPs

QUALIFICATIONSTraining & Education Preferred: ​Bachelor degree or above, major in pharmacy or other science-related background.

Prior Experience Preferred: 2-3 years regulatory related experience

English Skill: TOEIC Score≧650

Technical Skill Requirements:

• Professional expertise in local pharmaceutical regulations

• Good communication skill

• Problem solving

• Project Management

• Teamwork

• Strategic thinking

• Negotiation

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

Regulatory Affairs