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[UPJ] / Upjohn GRA Japan Sr. Regulatory Affairs Lead

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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.


(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.

**Senior Leader**

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.


**Financial Accountability**

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**

**/ Description of Primary Role & Responsibility**

Upjohn GRA Japan


**/ Qualifications**

**/ Desired Behavioral and Technical Skills**



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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: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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[UPJ] / Upjohn GRA Japan Sr. Regulatory Affairs Lead


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