CMC Scientist / Biopharma

勤務地: 東京   業種: 薬剤,医薬品   

英語力: 上級   日本語力: 母語   職 ID: 10094

職務内容
SUMMARY OF THE ROLE:
- Leading overall chemical manufacturing & control (CMC) related activities for product development in Japan
- Achieve NDA (including sNDA) submission and approval on schedule in Japan through collaboration with global scientists
- Provide scientific/technical expertise to fulfill clinical development plan on schedule in Japan
- Make a scientific contribution for product life cycle management to enhance the values of products in Japan market
- Support due diligence review of external opportunities for in licensing of molecules and/or technologies in line with Company’s strategic goals


KEY TASKS AND RESPONSIBILITIES:
- Act as a key person to coordinate CMC and/or regulatory science issues between global and Japan so that appropriate solutions are provided
- Be responsible for preparation of AAF, QOS and module 3 for Japan NDA submission
- Be responsible for preparation of AAF and STED for device registration
- Be responsible for preparation of answers to CMC inquiries from PMDA
- Closely contact with global CMC/molecule leader so that the most updated CMC status/information is shared
- Assess regulatory compliance of materials and their specifications (API, excipients and product) in advance for initiating Japan project
- Provide key information of CMC regulatory guidelines to global counterpart so that appropriate CMC strategy is developed
- Collection and share scientific, technical-related and specialized information from inside and outside resources
- Identify critical scientific/technical issues well in advance to avoid or minimize the risk for development plan
- Develop and expand active communication link within Japan project team to initiative good collaboration
- Collaborate global business development regarding new licensing-in compounds on CMC area

REQUIRED SKILLS AND ABILITIES:

Education / Language required:
- A degree (BS/MS/PhD) in a scientific field or equivalent/higher specialized knowledge
- English and Japanese fluency: good verbal and written skills mandatory

Professional Skills and Experience required:
- 5-7 years or more experiences for CMC NDA dossier preparation (CTD module 2, module 3) and supplemental NDA (partial change, CTD module 2 and 3)
- Good professional experiences in CMC activities (e.g. formulation development, analytical development, API and DP manufacturing etc.)
- Knowledge of ICH guidelines and GMP, especially requirements for regulatory submissions
- Familiar to global pharmaceutical product development processes
- Business knowledge
- Experience of leading global projects

Personal Skills and Competencies:
- Ability to work in a structured, reliable and customer centric manner, and to communicate effectively focusing on the key messages
- Be collaborative with all related functions/people
- Good personal organization, which can be shared with others
- Leadership - action guided by experiences
- Problem solving and decision skills
- Negotiating skill - logical approach
- Being assertive and able to work under pressure
- Creativity and innovativeness
- Must be familiar with it tools. Mandatory are word, excel and power point
- Other office applications as well as knowledge forecasting tools are an advantage

 
最新の仕事
言語を選択
フォローする
1-4-2 Minami Aoyama, Minato-ku, Tokyo, Japan 107-0062
Close
Oops, an error occured

An unknown error occured while executing your last action.
If you're seeing this message for the first time, please try to reload the page or close your web browser before starting again.
In the other case, please contact the administrator or report the problem using this form.