Pfizer UPJ / Upjohn GRA Japan Sr. Regulatory Affairs Lead in Tokyo, Japan
The Sr. Regulatory Affairs Manager, Supervise all Marketing Authorization related tasks in Japan for the assigned products and lead development & regulatory strategy for the projects in collaboration with the team and other function lines. Contribute the research, development and life-cycle management of pharmaceuticals by independent awareness of all registration approval-relevant tasks in Japan for the assigned products and development projects. Senior Regulatory Affairs Manager fulfills these tasks taking into consideration of Japanese Pharmaceutical & Medical Device Act and other regulations. Have good communication skill with health authority and external stakeholders. Represents the department inside and outside as Regulatory Affairs Japan, Upjohn GRA.
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
Responsible for oversight, support and developing of a team consisting of Regulatory Affairs Manager, Regulatory Affairs Specialists, etc.
Leads cross-functional teams
Training and instruction of trainees
Agreement on performance objectives according to the departmental goals and ensuring the achievement of the goals.
Takes appropriate and calculated risks to positively impact business outcomes.
Escalates issues with significant business impact where necessary.
Actively works to ensure teams have the right balance of skills and resources to support current and future business needs.
Achieve the approval of new drugs registrations and medical devices ensuring regulatory compliance:
Consideration of the regulatory requirements of the Japanese Pharmaceuticals & Medical Device Act as well as all national and international regulations and guidelines relevant for the registration of medicinal products
Determination, assessment and implementation of the optimal regulatory strategy in consultation with regional and global colleagues incl. review, and if necessary, preparation of the required registration documents
Leading Scientific Advice Meetings, incl. preparation of application forms, critical review and if necessary partial preparation of briefing document, external and internal agreement for time slots
Timely and appropriate processing of health authority queries and questions. Prompt communication of all relevant information with all internal stakeholders
Pharmaceutical Information / Labeling
Ensuring the compliance of all medicinal products registered in Japan
Creation and continuous adaptation of all legally required documents of the information of the medicinal product as well as their punctual implementation
Ensuring the timely implementation of all labeling changes
Maintaining the information texts in the global data management system
Supervision of clinical trials in collaboration with internal and external organizations:
- Compilation, submission and electronic archiving of clinical trial documentation
Support of In- and Out licensing activities:
Selection advice of suitable contract partners
Execution and documentation of "Due diligence"
Professional recommendation on the exercise of the purchase option
Contract review for registration-relevant agreements
Preparation of the requirement specification for allocation of registration projects to third parties
Coordination and monitoring of cooperation with all project participants
Contact with internal and external customers, business partners and associations:
Participation in the design of amendments to Japanese laws and regulations as well as the general framework of drug registration through pharmaceutical trade associations.
Responses to internal regulatory inquiries e.g. Medical Information queries
Preparation of regulatory and scientific assessment reports
Participation in project teams and working groups
Regulatory Business Intelligence Technology:
Oversight of maintenance of all regulatory databases for the assigned product portfolio and in line with Pfizer`s global and local SOPs and Work Instructions
Support for Continuous Improvement of all regulatory databases and frequent data quality and compliance checks according to global and local guidance
Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.
Education and Experience:
Bachelor's degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science), preferably doctorate or Master of Science and registered pharmacist
With proof of the appropriate professional qualification, other professional qualifications are possible, such as medical studies, other life science disciplines or sciences (Regulatory Affairs Manager)
At least 5 years of experience in pharmaceutical Regulatory Affairs
Poised for international environment
Technical and/or other job-related skills:
Extensive knowledge of Japanese pharmaceutical regulatory environment and experience with the relevant registration procedures
Experienced in information technology systems
Business fluent in Japanese and English (speaking & writing)
Diligent and careful working
Very good self-organized and excellent time management
Ability to collaborate in international and interdisciplinary teams
Project management experience
Leadership experience is an advantage
Willingness toward regular training and qualification
PHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements)
Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity. Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
- This position/role works in an office where physical requirements are consistent with typical office functions & activities. This position must also be affiliated with a Pfizer facility.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
(not all roles will have non-standard work schedule travel, or environment requirements)
Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.
Minimal travel may be required.
Owing to the global departmental footprint, occasional work outside of conventional working hours may be needed.
CORE COMPETENCIES (Applicable only for the Senior Leader or Manager roles and global job levels indicated below)
Select the 3-5 competencies most critical for the successful performance of this role from the appropriate Pfizer Core Competency set below. Please only choose selections from appropriate section.
Global Job Level J120+ (Vice President, US Grades 21+)
All roles Global Job Level J090+ (Sr. Manager-Sr. Director); and People (Colleague) Manager roles J060+ (Sr. Associate/Scientist US Grades 7-20)
☐ Anticipates Customer & Market Needs
☐ Grows Leaders
☒ Demonstrates Business Acumen
☒ Leads Change
☐ Strategic & Innovative Thinking
☐ Builds Change Agile Organizations
☐ Acts Decisively
☐ Acts Decisively
☒ Seizes Accountability
☒ Commits to "One Pfizer"
☐ Seizes Accountability
☐ Insight, Influence & Inclusion
☐ Holds People Accountable
☒ Builds Effective Teams
☐ Holds People Accountable
☐ Commits to "One Pfizer"
☐ Grows Others
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.
R&D, Safety, UGS, MA, Commercial functional managers
Country regulatory managers
Regulatory authority reviewers, administrators &/or inspectors.
External partners, trade associations, CROs, consultant & contracted resources.
Indicate the Average Budget or Revenue accountability, as applicable.
- Not applicable
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
- Not Applicable
１．主な職務における成果責任/ Description of Primary Role & Responsibility
Upjohn GRA Japanシニア レギュラトリーリードは、日本の薬事規制に関する専門知識と経験を持ち、アップジョンの開発品および既存製品に関する薬事規制の評価を独自に実施し、日本およびグローバルチームと連携して医薬品開発や製品ライフサイクルのあらゆる側面に渡り、薬事の代表者としてプロジェクトに貢献することで、アップジョン製品を一日でも早く患者に届けることを目指します。
【資格・能力要件/ Desired Behavioral and Technical Skills】
Microsoft Office SuiteおよびDocumentumベースのアプリケーションを使用したコンピュータ・リテラシーが非常に高く望まれる
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.