メディカル・バイオ - 薬事申請

新薬承認申請業務
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■休日：完全週休二日制, 土, 日, 祝日

Position Requirements: In the following categories, indicate specific role requirements and qualifications that are absolutely necessary in order to perform the essential functions of the job.

Knowledge & Experience
•Prior experience in gene therapy and/or orphan (rare) diseases in Japan, strongly preferred. Strong working knowledge of biologic development within Japan is required
•Prior experience serving as the Japanese regulatory lead within a global matrixed organization
•Ability and experience in the development and execution of regulatory strategy in Japan
•In-depth knowledge and direct application of Japan/International regulations, regional and ICH guidance documents
•Regulatory writing and/or review of documents supporting product development and clinical trials in Japan
•Strong working knowledge and experience with electronic submissions (eCTD)

Qualifications
•Bachelor’s degree in scientific discipline required. Advanced degree in a scientific or regulatory discipline (Master's/PhD/PharmD) preferred.
•Minimum of 10 years of experience in Japanese Regulatory Affairs, and/or relevant product development experience (biologics) within the pharmaceutical or biotechnology industry, preferably with 5-7 years of gene therapy orphan (rare) drug development experience.
•Knowledge or direct experience of neurology and/or ophthalmology drug development is a plus
•Proven experience with initial CTN submissions and lifecycle maintenance, ideally within the regenerative medicine space
•Prior experience in J-NDA and CTx applications is desirable
•Prior experience leading direct interactions with PMDA/MHLW is required.

Skills
•Strong team player with the ability to collaborate effectively across multiple functional areas and Global regions
•Proven ability to lead cross-functional initiatives and build effective partnerships
•Manage multiple priorities in a fast-paced, growing organization
•Exceptional written and verbal communication skills (English and Japanese), including regulatory writing
•Highly organized with a strong attention to detail, clarity, accuracy, and conciseness

Other (if applicable):
•Excellent planning, and follow-up skills
•Must be a self-starter with the ability to be flexible to meet the business needs
•Computer proficiency with MS Office Suite programs, Adobe Acrobat, and Veeva Vault
•High ethical standards for compliance with regulations and procedures
•Initiative, combined with a high energy level is critical to success
•Expected to exhibit Insmed’s five (5) core values of Collaboration, Accountability, Passion, Respect, and Integrity
•Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

■職種未経験者：不可