Manager, Regulatory Submissions

1ヶ月前

Minato, Tokyo AbbVie

企業概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

求人内容

The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams.
Objectives
With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a discipline expert and resource in regulatory affairs submission management.

Key Responsibilities

  • Independently manages high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
  • Acts as primary Submission Management interface with project teams providing guidance and communication of established submission processes and standards. Plans and negotiates submission project scope, publishing timelines and deliverables.
  • Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
  • Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues
  • Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
  • Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance's including verification of content, bookmarks, hypertext links and tables of content in complex submissions. Facilitates team reviews.
  • Actively contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Creates, implements and finalizes internal process and standards documents relating to publishing and publishing deliverables.
  • Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions May lead or participate on internal project teams to update business software.
  • Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.

  • Position accountability/scope:

  • Minimal supervision required(People Manager)

  • Receives project assignments from manager but has responsibility for managing own projects
  • Reviews project progress with manager on a regular basis with direction provided on follow-up
  • Provides estimates of activities with budgetary impact.
  • Trains, mentors and may supervise the work of less experienced staff.

資格

Qualifications
Bachelor's degree

Note: Years of experience may also compensate for lower education.

PMP and RAC certificates desirable.

Competencies

  • Pharmaceutical or industry related experience
  • Experience working in a complex and matrix environment
  • Strong communication skills both oral and written
  • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
  • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
  • Proven leadership skills and presence

その他の情報

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

  • Manager, Regulatory Submissions

    1ヶ月前

    Minato, Tokyo AbbVie ￥2,000,000 - ￥2,500,000 per year

    The Manager, Regulatory Submissions role at AbbVie involves managing high-impact submission projects, establishing content planners and timelines, facilitating team meetings, and ensuring timely delivery of high-quality dossiers.Key Responsibilities include independently managing ...

  • CMC RA Manager

    1ヶ月前

    Minato, Tokyo AbbVie ￥600,000 - ￥1,800,000 per year

    Deliver the qualified drug timely to the patients by contributing to the regulatory approval of the new drug as the CMC responsibility person and updating regulatory commitments of the marketed products according to CMC variations. · ...

  • Regulatory Submission

    2ヶ月前

    Minato, Shizuoka Barrington James ￥900,000 - ￥1,200,000 per year

    Regulatory Submission Lead · Experiența: · 5 ani de experiența àn poziția de Sr. Associate · 8-10 ani de experiența àn poziția de Consultant · Competențe: · Crearea, prezentarea àn eCTD a documentelor àn legâturà cu reglementàrii · Utilizarea sistemelor de reglementare àn nivel g ...

  • Principal Medical Writer

    6日前

    Minato, Shizuoka BioSpace

    The Principal Medical Writer (PMW) is the accountable lead for his/her compound(s). · The PMW works closely with Medical Directors, Biostatisticians, Regulatory Liaisons, and others to develop high-quality clinical documents and is responsible for helping to drive document strat ...

  • Director for RW DC Bios

    1ヶ月前

    Minato, Tokyo IQVIA ￥20,000,000 - ￥40,000,000 per year

    The Director of Biostatistics will oversee a department of biostatisticians and statistical programmers to ensure target productivity levels are met. · ...

  • Clinical Pharmacology Manager

    2ヶ月前

    Minato, Tokyo AbbVie ￥5,000,000 - ￥10,000,000 per year

    Clinical Pharmacology Manager at AbbVie. Contribute to Japan clinical development by providing scientific guide from clinical pharmacology aspects. · Represent from Clinical Pharmacology and drive projects forward in clinical development by providing clinical pharmacology aspects ...

  • Associate, Study Management III

    1ヶ月前

    Minato, Tokyo AbbVie ￥4,000,000 - ￥6,500,000 per year

    As a Study Management Associate III at AbbVie you will be part of a dynamic centralized study management team responsible for executing global clinical trials. · ...

  • QA Specialist

    4週間前

    Minato, Tokyo Tate & Lyle $90,000 - $120,000 per year

    The QA Specialist will support customer support and ensure documentation complies with local regulations. · ...

  • Director, Regulatory Affairs

    4日前

    Minato, Tokyo IQVIA

    We are seeking a Regulatory Affairs Director to support our RADDS Japan team in supporting EBP initiative for business growth in RD&S. · ...

  • Manager - Control Management (RCSA)

    3日前

    Minato, Tokyo American Express

    At American Express our culture is built on shared values leadership behaviors and an unwavering commitment to back our customers communities and colleagues. · ...

  • Senior Specialist or Manager, Study Execution Team, Evidence Solution Group, Medical

    2ヶ月前

    Minato, Tokyo AbbVie ￥5,000,000 - ￥10,000,000 per year

    The Senior Specialist or Manager of Study Execution Team, Evidence Solution Group. Medical is responsible for on-time study execution upon regulatory Post Marketing Observational Studies (reg-PMOS) and non-regulatory non-interventional studies. · Work as a study manager according ...

  • Director - Control Management (RCSA)

    3日前

    Minato, Tokyo American Express

    We are looking for a Risk and Control Management Director to lead our RCSA program in Japan. · ...

  • Analyst, ICS Control Management

    1週間前

    Minato, Tokyo American Express

    We are seeking an Analyst to join our ICS Control Management team in Japan. The successful candidate will be responsible for ensuring control management is embedded in the day-to-day operations of our business and providing specialized and strategic operational risk advisory to t ...

  • Global Banking

    1ヶ月前

    Minato, Tokyo Goldman Sachs ￥2,000,000 - ￥2,500,000 per year

    We're looking for a professional to join our management and strategy team in Japan who wants to use their analytical skills and professional abilities to positively impact the operating performance of the FICC/Equities business. · ...

  • Capital Management

    1ヶ月前

    Minato, Tokyo AIG ￥800,000 - ￥1,040,000 per year

    The Capital Management analyst position will support all capital-related functions for AIG Japan at both the holding company and subsidiary level. · Capital Management supports the AIG Finance team in statutory Capital and dividend planning and decision-making. · The Capital Mana ...

  • マネージャー & カウンセル

    3週間前

    Minato, Tokyo American Express ￥8,400,000 - ￥10,000,000 per year

    As part of Team Amex at American Express in Tokyo you'll experience comprehensive support for your holistic well-being many opportunities to learn new skills develop as a leader grow your career voice ideas matter work makes an impact together you will help define future of Ameri ...

  • Pipeline MSL, Oncology

    3週間前

    Minato, Tokyo AbbVie ￥4,500,000 - ￥7,500,000 per year

    Pipeline Medical Science Leads are key members of the affiliate medical department. · ...

  • Associate Director, Global Patient Safety

    2ヶ月前

    Minato, Shizuoka BioSpace ￥15,000,000 - ￥25,000,000 per year

    The Associate Director shall report to GPS Director in Japan and performs as deputy Anseki (Safety Control Manager) and Choseki (Post-Marketing Surveillance Manager) as needed. · Serve as the primary backup for the Head of Japan PV including but not limited to acting as the Deput ...

  • Sales Account Manager

    2ヶ月前

    Minato, Tokyo The Chemours Company ￥4,000,000 - ￥10,000,000 per year

    Chemours is seeking a Sales Account Manager (Japan) to join our growing Titanium Technologies Asia Pacific commercial team. · Manage key accounts, develop annual account plans with strategies and objectives and execute against quarterly and annual sales objectives · Develop and m ...

  • Director, Medical Affairs Oncology, Japan

    5日前

    Minato, Shizuoka BioSpace

    Job summaryWe are Regeneron a global leader in biotechnology dedicated to transforming lives through innovative medicines. · ...

  • Director, Medical Affairs Oncology, Japan

    1ヶ月前

    Minato, Tokyo Regeneron ￥1,200,000 - ￥3,000,000 per year

    We are Regeneron, a global leader in biotechnology, dedicated to transforming lives through innovative medicines. As the Director of Medical Affairs Oncology in Japan, you will play a pivotal role in advancing our oncology assets and pipeline. · Act as the local medical contact f ...