Associate Director of Regulatory CMC

Publication date 2025/08/18

Work Location , Expected Annual Income :

Tokyo,14.0M ～ 16.0M

About the Company :

Global American Pharmaceutical Manufacturer

Responsibilities :

Position Overview
?May serve as a Core member of the cross-functional PDM Project Team (region specific).
?Regional Regulatory Lead on Regulatory Project Teams.
?Regional Lead and may lead cross-functional /cross- regional Regulatory Submission Teams.
?Participates on other Sub teams, as applicable.
?Serves as contact with local Regulatory Authorities.
?Some positions at this grade level may partially or wholly include oversight of computerized systems.

Job Responsibilities
?Responsible for preparing and/or overseeing the preparation of technically complex regulatory CMC submissions which require extensive interaction with departments outside of Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and CTNs for assigned territories.
?Provides strategic regulatory CMC advice as appropriate.
?Oversees preparation and maintenance of country specific labeling and product packaging (region specific).
?Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
?Ensures up-to-date knowledge of regulatory CMC requirements and communicates relevant changes in regulatory information to project teams and senior management in a timely manner.
?Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or other departments.
?Plans, schedules and arranges own activities and those of direct reports (if applicable).

Benefits :

Employment Type: Full time employee
Office Location: Tokyo, Japan
Working Style: Hybrid Work Model
Budget Range: 14~16mil annual total.
Interview Steps: 3
Language: Japanese and English

Required Experience / Abilities / Skills :

KNOWLEDGE & SKILLS
?Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines.
?Excellent verbal and written communication skills and interpersonal skills.
?In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs CMC.
?Capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
?Capable of assuming leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of
actively participating in a broader cross functional team for implementation
of major changes (region specific).
?Capable of leading a team in preparation of complex regulatory submissions and maintenance of licenses.
?Work is performed under consultative direction towards corporate regulatory goals and objectives.
?Is recognized as a knowledgeable resource for CMC Regulatory Advice in other departments.

EDUCATION & EXPERIENCE
?10+ years of experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.
?Degree in a scientific field is preferred.

Contact Information :

JAC International, Healthcare Team
Kent Gu
Email: k-gu@jac-international.jp

If you are interested, email us for an inquiry!

JOB ID : IJB2009840