Global Branded CMC Strategy Japan -Director

Viatris Pharmaceuticals Japan G.K.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via: 
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

Job Purpose Overview

The Director Global Branded CMC Strategy is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The position is primarily devoted to the independent development of strategic CMC regulatory approaches to expedite the preparation and review of regulatory submissions in support of Viatris’ branded product portfolio.

Roles & Responsibilities

1.Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.                             

2.Interprets CMC regulatory requirements, develops strategies (including novel approaches), assesses risks and develops contingency proposals.

３．Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control.  

4.Ensures all CMC regulatory activities are executed effectively & efficiently, and in compliance with external regulatory requirements & internal quality procedures.          

5. Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.

6.Presents and articulates issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.                             

7.Manages, leads and contributes significantly to Upjohn projects and initiatives within cross-functional project teams                                 

8.Serves on governance & steering committees        

9.Executes training related activities (e.g. compliance-related, HR policies) & individual development plans, participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk & Listen exchanges, demonstrates and models adherence to all Viatris’ behaviors & values, embraces & complies with Principles of Integrity.

10. Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.  demonstrates and models adherence to all Viatris’ behaviors & values, embraces & complies with Principles of Integrity.

11.Manages CMC responses in response to MedInfo queries

12.May serve as the global CMC lead in Due Diligence exercises                      

13.Performs other duties as assigned.

■Team Management

・Provides guidance & direction to direct reports, managing resources, resource capacity & budget along with prioritizing workload appropriately.

・Accomplishes performance-management & training related activities, encourages & supports a healthy work/life balance, supports roll-out of HR policies, takes hiring-related decisions, participates in succession planning, provides guidance & facilitates opportunities for talent development, encourages colleague participation in cross-disciplinary forums & learning opportunities, engages colleagues in Straight Talk & Listen exchanges, demonstrates & models adherence to all Viatris’ behaviors & values, embraces & complies with Principles of Integrity.

・Serves as the primary reviewer of global CMC strategic plans and documentation/submissions

Requirement Experiences & Skills

KNOWLEDGE 
•  Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 5+ years
•  High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects. 
•  Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle.
•  Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.
•  Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives

A minimum of 8-12 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 6 years pharmaceutical regulatory experience required. A combination of experience and/or education will be taken into consideration

SKILLS AND ABILITIES
•  Advanced skills in written & oral communications (mandatory). 
•  Computer literacy with Microsoft Office Suite and Documentum-based applications.
•  Prior experience (minimum of 5+ years) managing projects and matrixed teams and/or serving as a people manager
•  Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel. 
•  Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
•  Ability to engage in the external regulatory and pharmaceutical environment.
•  Proven ability to deliver to time, cost and quality standards
•  Demonstrated strategic thinking and ability to integrate strategies into actionable plans
•  Demonstrated experience serving as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

SUPERVISION
As a People & Matrixed Project Team Manager:
Position may typically manage few internal colleagues, as well as contractors, resources across a matrixed and global organization.

Educational Requirements

Minimum of a Bachelor's degree (or equivalent).  A Master's degree (or equivalent) preferred.

Language Skills

Ability to read and interpret comprehensive and intricate research documents in both English and Japanese.  Ability to write scientific reports and technical correspondence.  Ability to work with executives and communicate abstract concepts.   Ability to present to a high level of the organization and groups outside of the organization.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.