Manager, MAH License

2週間前

Chiyoda City Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Key Responsibilities and Major Duties:

  • Handle authority request and notifications by collaborating with Regulatory and Quality Assurance department, and coordinate within BMSKK accordingly.
  • Manage the change appropriately for market-authorized products in cooperation with BMS Global as well as BMSKK associated departments.
  • Regarding the change control proposed by BMS-Global, coordinate with relevant internal departments, and appropriately assess the impact on Japan.
  • Manage discrepancies between the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing situations.
  • Periodically check whether there is any discrepancy between the approval file (Manufacturing site information, manufacturing process, test/inspection items, and other necessary information) and the actual manufacturing status. If any discrepancy is found, draw up a regulatory strategy and respond to the regulatory authority in cooperation with related departments.
  • Formulate and propose regulatory strategies such as application for GMP/GCTP compliance inspection and Foreign Manufacturer Accreditations renewal. Also, complete these tasks as scheduled.
  • This position can be a designee for a director of MAH license and compliance for GMP compliance inspection submission and FMA management, AF verification, change control and GMP/GCTP audit verification.

    • Required Knowledge and Skill

    Knowledge

  • Knowledge of Pharmaceutical & Medical Device Act. and related regulations, GQP ministerial order and GMP ministerial order.
  • Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
  • Knowledge of regulatory application for obtain/renew Foreign Manufacturer Accreditations and periodical GMP compliance inspection etc.

    • Skill

  • Communication skill for achieving good relationship with authorities and connected departments.
  • Strong leadership skill to perform cross functional tasks.
  • Logical thinking to make regulatory strategy.
  • Capability to have Global team and foreign manufacturers understand pharmaceutical regulations and notifications that is imposed to Japanese Market Authorization Holder.
  • Capabilities to obtain accordingly, information necessary to obtain/renew Foreign Manufacturer Accreditations and periodical GMP compliance inspection from the manufacturers (API site, Formulation site, etc).
  • Capabilities of analysing the supervising results of manufacturing sites and make instructions for improvement if necessary.
  • Skill to negotiate with PMDA officer on regulatory application and inquires.

    • Language skills

  • Communication skills in fluent Japanese and business level of English
  • Analyse English documents

    • Uniquely Interesting Work, Life-changing Careers
    With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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