Senior Regulatory Sciences Specialist

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 RESPONSIBILITIES

Product 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

QUALIFICATIONS

Training & 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