Position Purpose

Achieve successful filing and approval of the following CMC dossiers in Japan with sophisticated CMC regulatory strategies.

NDA for NCE (New Chemical Entities)Life cycle management of NCEPost-approval change management of NCE

Role & Responsibility

Fostering and actively developing talentsBuild up and maintain cooperative relations with following relevant stakeholders: Global CMC, GRS, PharmSci, PGS, CQSA and Development JapanExercise and maintain engagements/relationships with regulatory authoritiesSet department objectives with middle-term objectives and manage multiple projects/non-project activitiesEnsure timelines and quality of all tasks in the departmentPrioritize tasks and allocate staff appropriately/flexibly in the departmentSupervise/advise staff to achieve individual and department objectivesManage budget and budget for the coming yearFind out common issues in the department and provide/execute best countermeasures

Desired Skills

1. Behavioral Skill

Demonstrate leadership & ability to engage disciplines at cross-functional levelSelf-motivated in developing technical/regulatory leadershipFocus on balancing business needs with regulatory expectationsDriven to identify innovative & effective opportunities to expedite regulatory approvals

2. Technical Skill

Applied knowledge of CMC discipline in Pharmaceutical industryNegotiation skills with internal/external stakeholdersFamiliarity with regional regulatory requirements in CMC discipline and interpret these into business objectives

3. Experience

Applied experience in developing & preparing regulatory submissions10 years of experience in CMC discipline in Pharmaceutical industry 5 years of experience in people management (not essential)

4. Education / Certification

Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) and/or technical disciplineTOEIC score of 730 or higher

  
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.

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