Japan Regulatory Affairs Operations Manager

6日前

Tokyo Biogen Full time

Job Description

Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen.

Manage and maintain regulatory operational activities in drug development, NDA filing, NDA review, and post marketing stages (e.g., CTN, NDA/sNDA, JPI) in Japan based on the depth knowledge on Japanese regulation.

Develop and maintain procedures necessary to perform JRA activities in compliance with regulatory affairs and global policy/SOP

Support to maintain marketing business licenses in Japan according to the regulation

Key Responsibilities:

  • Lead regulatory operation activities in Japan in collaboration with global and relevant functions.
  • Identify appropriate resources/strategies needed to deliver on schedule with high quality.
  • Responsible for regulatory submissions such as CTN, CTN amendment, and eCTD
  • Document management within JRA, communicating with global RA
  • Manage and maintain Japan labeling for all products according to global procedure and company core data sheet. Responsible for proper JPI format and consistency within Biogen products.
  • Manage and coordinate venders to prepare necessary documents for submission to meet the timeline
  • Support to maintain marketing business licenses in Japan according to the regulation
  • People management of Senior associate and temporary staff

    • Qualifications

    Essential Skills and Qualifications Required:

  • Has sufficient knowledge and understanding of pharmaceutical regulations and is able to grasp the latest pharmaceutical regulations at all times.
  • Ability to accurately interpret regulations and appropriately execute pharmaceutical dutiesCommunicate appropriately with various stakeholders to achieve goals
  • Drive regulatory operation team
  • Advanced knowledge of global/local system related to regulatory affairs, such as e-submission, change control.
  • Extensive knowledge of handling Japan labeling creation including communication with PMDA and ability to assess appropriateness and consistencies among JPIs and CCDS.
  • High fluency in English (business level) and Japanese

    • Education:

  • BA/BS/University degree required; Life/Health Sciences preferred.

    • Experience:

  • 5 years+ biotechnology or pharmaceutical experience
  • 3-5 years' experience in regulatory affairs or equivalent experience/education
  • Good knowledge and understanding of regulations.
  • Ability to interpret regulation

    • Additional Information

    Why Biogen?

    Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

    At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts

    • Senior Manager, Regulatory Affairs, Japan

      8時間前

      Chiyoda Jazz Pharmaceuticals Full time

      JOB PURPOSE · The Manger, Regulatory Affairs, Japan shall manage regulatory activities assigned in GW Pharma order to obtain new drug application(NDA) approval, partial change application(PCA) approval, to submit appropriate minor change notification(MCN) and to execute other ne ...

    • Associate Director, Regulatory Affairs Japan

      3日前

      Tokyo BioMarin jobs.contract_type_full_time-Regular

      JOB DESCRIPTION · Job Title: · Associate Director, Regulatory Affairs Japan · Department / CostCenter: · Regulatory – 210 · Reports to (Job Title): · Head of APAC Regulatory Affairs · Job Code: · Location: · Tokyo · Date Prepared: · April 2024 · Full-Time Part-Time · Regular Te ...

    • Regulatory Affairs Manager

      7日前

      Tokyo Galderma Full time

      With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...

    • Regulatory Affairs Manager

      1週間前

      Tokyo Philips Full time

      Job Title · Regulatory Affairs ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. ...

    • Regulatory Affairs Manager

      2日前

      Tokyo Philips Full time

      Job Title · Regulatory Affairs Manager (SRC)Job Description · Job title: · Regulatory Affairs Manager · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innova ...

    • Regulatory Affairs Manager

      1日前

      Tokyo Philips Full time

      Job Title · Regulatory Affairs ManagerJob Description · Job title: · Regulatory Affairs Manager · Your role: · Exciting opportunity to play an integral role in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities. · De ...

    • Operations Manager Japan

      2日前

      Tokyo Digital Charging Solutions GmbH Permanent

      · (Senior) Operations Manager Japan (f/m/d) at Digital Charging Solutions GmbH | softgarden · View job here Electrify your career · We believe the future of mobility is electric Join an enthusiastic international team with a common vision of the future of mobility and be part ...

    • Senior Manager, Public Affairs, Japan

      4時間前

      Tokyo Abbott

      1) Main Purpose of Role · Develop and execute strategic plans, programs and stories that deliver high impact results focused across 5 key areas: Storytelling, Media Relationships, Proactively Managing Issues, Engaging Employees, and Driving / Supporting the Business. Effectivel ...

    • Senior Manager, Public Affairs, Japan

      3日前

      Tokyo Abbott Laboratories Full time

      1) Main Purpose of Role · Develop and execute strategic plans, programs and stories that deliver high impact results focused across 5 key areas: Storytelling, Media Relationships, Proactively Managing Issues, Engaging Employees, and Driving / Supporting the Business. Effectively ...

    • Regulatory Affairs Senior Manager

      1日前

      Tokyo Philips Full time

      Job Title · Regulatory Affairs ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. ...

    • Regulatory Affairs Senior Manager

      1週間前

      Tokyo Philips Full time

      Job Title · Regulatory Affairs Senior Manager - IGTDJob Description · Regulatory Affairs Senior Manager · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through inno ...

    • Regulatory Affairs Senior Manager

      1週間前

      Tokyo Philips Full time

      Job Title · Regulatory Affairs Senior ManagerJob Description · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better to ...

    • Regulatory Affairs Manager, Head Pharmacist

      4時間前

      Tokyo Guerbet Long-term/regular

      Description · 1. General Marketing Compliance Officer (SOKATSU-SEKININSHA) Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH. Name and address are registe ...

    • Manager, Regulatory and Financial Crime Compliance, Japan

      4日前

      Tokyo Commonwealth Bank Full time

      You are a team contributor who enjoys working collaboratively · Opportunity to innovate and drive pioneering business initiatives · Together we can drive sustainable business growth for our clients · Do work that matters: · We're undergoing a rapid transformation, and Risk Manage ...

    • Senior Operations Manager Japan

      2週間前

      TOKYO AXA Group Full time

      Control of Fund accounting activity · NAV validation · Control the portfolio performances & Management fees · Financial Reports · Front Office Support · Oversee State Street Daily productions (Trade Management, Asset Servicing, Collateral Management) and Performances Attribution ...

    • Senior Operations Manager Japan

      2日前

      Tokyo AXA Group Full time

      Control of Fund accounting activity · NAV validation · Control the portfolio performances & Management fees · Financial Reports · Front Office Support · Oversee State Street Daily productions (Trade Management, Asset Servicing, Collateral Management) and Performances Attributi ...

    • eBay Japan Strategy Operations Manager

      4時間前

      Tokyo 0301 eBay Japan KK Full time

      Looking for a company that inspires passion, courage, and creativity, where you can be on the team shaping the future of global commerce? Want to shape how millions of people buy, sell, connect, and share around the world? If you're interested in joining a purpose driven communit ...

    • Japan – D2C Technical Operations Manager

      5日前

      Tokyo L'Oréal Jornada Completa

      Key Job Accountabilities 主要職務 · The DC Technical Operations Manager plays a pivotal role in enhancing our e-commerce presence, · focusing on optimizing our DC E-Flagship websites. This key position bridges technical expertise with · operational excellence, ensuring our digital ...

    • Clinical Compliance Operations Manager, R&D Japan

      4時間前

      Tokyo CSL Full time

      Position Purpose: · The Clinical Compliance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically align ...

    • Partner Operations Manager, Prime Video Japan

      4時間前

      Tokyo Amazon Japan G.K. Full time

      Prime Video (PV) is a digital video streaming and download service that offers Amazon customers the ability to rent, purchase or subscribe to a huge catalog of content. Movies range from new releases to classic favorites, and PV also offers major television shows, entire seasons, ...