Assoc. Director Regulatory Affairs, Biologics & Vaccine products

Assoc. Director Regulatory Affairs, Biologics & Vaccine products.

As a manager of Biologics ＆ Vaccine products group, CMC Regulatory Affairs Department of Japan Development Division, an experienced specialist who is willing to contribute in CMC Regulatory Affairs (RA) tasks through product life cycle managing from the initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls.

【Job Description】

Supervise group member’s tasks　（about 10 members）

• Collaborate with our HQ CMC RA members to appropriately advance the CMC development stage of the project in charge, and prepare CTD CMC parts (i.e. Manufacturing method, Specifications and test methods, and Stability) logically with high scientific quality.
• Identify product issues and assess risks from the CMC viewpoint, and plan countermeasures.
• Provide CMC-RA information obtained from regulatory authorities or industry associations to Japan/overseas relevant divisions, and discuss with them.
• Evaluate CMC-related changes and take appropriate RA action, if necessary.
• Appropriately respond to questions from the authorities on consultations or on review for approval, or negotiate if necessary. 

Others

• Evaluate group members’ performance, lead, develop and coach group members.
• Check and review the status of group members’ tasks, and control resource.
• Cooperate with our HQ or overseas sites through overseas business trips or teleconference to prepare the strategic countermeasures on CMC relating matters.

Required Qualifications

• Experience of coaching/supervising group members as a manager or Leader
• At least 5 years of Biologics or Vaccine products development experience in CMC Regulatory Affairs.
• Experienced in preparing PMDA consultation documents and dealing with issues.
• Experienced in preparing CTD and application form for approval, responding to inquiries on PMDA review and discussing with PMDA.
• Knowledge on CMC regulations (ICH Guidelines, Standards for biological materials, etc.) and basic knowledge on general pharmaceutical affairs (product life cycle management, etc.).
• Experience of commutation with overseas
• Master’s degree or above, in medicine, pharmacy, chemistry, or biology.
• Practical English speaking ability, presentation skills in English, and English documentation skills (TOEIC score 800 and over）.
• Practical skills in E-mails, Word, Excel, PowerPoint, Acrobat.
• High level of compliance awareness.

Desired Qualifications

• Experience at CMC labs or pilot facilities.