CMC Regulatory Science Expert  / Non Line Manager / Regulatory Science Expert Group CMC Dept

Basic Purpose of the job:

This position is responsible for preparing and reviewing CMC relevant documents as well as assessing and mitigating risks on clinical trials and NDA in Japan for New Molecular Entity projects in accordance to all applicable latest regulatory requirements and science (ICH, cGMP, SOPs, etc.) as well as in a proactive collaboration and coordination with BI partners.

This position is assigned as Dev JP TA rep and is responsible for mitigating CMC relevant risks on clinical trials and NDA in Japan by communicating with both global and local project teams.

Accountabilities - Related Performance Indicators:

Author and review all the CMC relevant documents for regulatory submission (e.g. CTD, IB, etc) in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) as well as the state of the art science

-Author and review the Common Technical Document (CTD), I.B. for quality section, quality consultation materials and CMC documents for CTN based on state-of-the-art regulatory requirements and scientific knowledge/experiences

-Review the key CMC documents (e.g. IF, PI etc).

-Interact with RA and D&D team on content and format of CMC documents

-Author JAN application document

Supervise/discuss with project teams from CMC aspects in preparing any clinical study plans and regulatory relevant documents in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) in view of future submission in Japan

-Proactively assess risks on future submission in Japan for all development projects

-Discuss with project teams to prepare regulatory relevant documents as well as development strategy in Japan

-Provide project teams with guidance in preparing any study plans, especially Bioequivalency study, in a way to enable successful clinical trials and regulatory submission in Japan.

-Contribute to establishing proactive response strategies

Interface to regulatory agencies (e.g., PMDA) based on the global strategy

-Interact with local regulatory bodies during the development (e.g, pre-NDA meetings, formal and informal discussions, etc.), submission and review

-Prepare responses to PMDA inquiries in alignment with global CMC consultancy team and SME

-For end of J-NDA review, update J-QOS, review PMDA's review reports and prepare masking of disclosure documents.

-Prepare data integrity inspection with QA and global SME.

-For clinical development/CTN, reflect PMDA's opinion into development strategy (e.g. formulation bridging, etc.) or relevant documents (e.g. CTN, Cartagena application)

Support product launch and customers 

-Provide additional CMC information (e.g. in-use stability/compatibility data, scientific explanation) of the products to the relevant functions and customers as requested  

Support internal and external innovations

-Support internal and external innovations in KPRI by providing expertise and networks

Support to develop expertise, know-how and competency of group members

-Coach staffs to acquire skills, help them solve problems and develop their career plans

Other regulatory and / or Organisational Requirements:

-PMD Act, relevant regulations/guidelines (e.g. NDA, GxP, ICH) and requirements for submission/approval in Japan

-Relevant global regulations/guidelinees and requirements for submission/approval (in paticular FDA and EMA)

Interfaces:

-Global R&D team, CMC-consultancy team, Global CMC experts NCE/NBE
-Local RA, Local CMC-RA, Local Project Team (Evidence team and Value team)

Required Education:

Masters Degree eg MBA or MSc　博士修了

Chemistry　化学

Required Capabilities (Skills, Experiences, Competencies):

Required Skills:

・Special Skills:

-Sufficient knowledge of the drug development for CMC part

-Developing submission strategy in Japan in accordance with Japanese drug regulations based upon scientific rationale

・Language Skills & Proficiency:

-Japanese: Native/Fluent

-English: Excellent oral and written presentation skills in English required

Requires Experience:

・Leading projects

・International Experience:

-One or multiple extended business trips (up to 6months) abroad

-Int'l exposure in daily business (>50%of international business / customers / staff) (1.5 - 4 years～)

-Work abroad (1.5 years～)

・Special Work Experience

-7-10 years of experience in an international or local pharmaceutical R&D organization

-Strong CMC background with proven performance record (not less than 3 projects)

-International work experience (cross-cultural competence)