1+ months

[R&D] Sr Director Global CMC

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The Senior Director of Global CMC-Japan is a senior leader position in the Global CMC organization and member of the PTxCMC Leadership Team. This position is also a member of the Development Japan Leadership Team. This is a people leader role, providing direction on CMC regulatory strategy for Pfizer's entire Japanese portfolio of marketed and development products, including both small and large molecules programs.


+ Managing colleagues within a GCMC-Japan function (approximately 25 colleagues)

+ Providing guidance & direction for direct reports, managing global resources & resource capacity along with prioritizing workload appropriately.

+ Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

+ fostering & actively developing GCMC talent

+ Exercising & maintaining engagements / relationships with regulatory authorities, specifically the PMDA and MHLW

+ Participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.

+ Cultivating sustainable & effective relationships with Development Japan, GCMC teams in the US and Eurpoe, as well as other internal partners, i.e., R&D (PTx, BTx,), PGS, GRA, BU's, etc.,

+ Manage, lead and contribute significantly to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.

+ Demonstrating ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

+ May serve as CMC representative on Project Teams and/or Pfizer project governance bodies & steering committees to achieve consensus for GCMC strategies.

+ May serve as GCMC lead of a core project portfolio (multiple projects) and/or Due Diligence exercises.

+ Leads collaboration within & across divisions, working with other scientific & technical leaders, to establish aligned approaches to regulatory strategies and/or policies.

+ Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.

+ Demonstrating ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.


Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.


+ Technical discipline with **12+ years** of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and **8** **+** years pharmaceutical regulatory experience.

+ Demonstrated history of successful interactions with the PMDA and MHLW.

+ Recognized as a technical subject-matter expert with extensive relevant regulatory experience & business knowledge, a leader and strategist capable to lead interactions with regulatory agencies for assigned projects and programs. One whom exercises independence in judgment and decision-making principles to influence regulatory & business strategy, guiding complex projects with broad impact and balancing risk with organizational flexibility & business needs

+ 6+ years management & supervisory experience with technical projects and/or staff.


+ Development Japan

+ PTxCMC, BTxCMC and VTxCMC functional leaders

+ PGS local (Japan) and global leaders

+ R&D (PTx, BTx and VTx) functional leaders & managers

+ GRA functional & regional leaders & managers

+ Relevant Japan BU category leaders, Chief Pharmaceutical Officer

+ Appropriate governance & advisory bodies, i.e., PDT, BMT, Councils & LTs, steering committees, prioritization teams, cross-disciplinary operational teams and LDTs

+ Regulatory authority reviewers, administrators &/or inspectors globally, i.e. PMDA, MHLW

+ External partners, CMOs, CROs, consultant & contracted resources.

Position reports to the Executive Director PTxCMC in the Global CMC Organization.

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

Regulatory Affairs

Posted: 2021-03-15 Expires: 2021-05-15
Sponsored by:
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