Basic Purpose of the job

This position is responsible, as a CMC Regulatory Science Expert, for writing and reviewing CMC relevant documents as well as assessing risks on clinical trials and future submission in Japan for all Boehringer Ingelheim projects (New Molecular Entity) in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) as well as in collaboration and coordination with Boehringer Ingelheim partners.

Accountabilities

1. Author and review the CMC relevant documents for regulatory submission (e.g. CTD, Investigators Brochure, etc) in Japan in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.)

Related Performance Indicators

-Author and review the Common Technical Document (CTD) and I.B.for Japan in quality sections in alignment with global documents.

-Review the key CMC documents in the department

-Interact with global/local regulatory affairs and R&D team on content and format of CMC documents

2. Contribute the project team from the 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

Related Performance Indicators

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

-Consult the project team to prepare regulatory relevant documents as well as development strategy in Japan

-Provide the project team with guidance in preparing any study plans in a way to enable successful clinical trials and regulatory submission

-Contribute to establishing strategies of proactive response to the health authorities in alignment with global documents.

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

Related Performance Indicators

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

Other Requirements

• Understanding Pharmaceutical Affairs Law and the relevant regulations in Japan

• Experiences/knowledge of the drug development in the CMC laboratories

• Knowledge/experiences of new drug applications in Japan for CMC part in accordance with Japanese drug regulations based upon scientific rationale

• Excellent oral and written communication skills in English

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.