-
Abbott Tokyo, 日本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 ...
-
Abbott Laboratories Tokyo, 日本 フルタイム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 ...
-
Biogen Tokyo, 日本 フルタイム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, ND ...
-
Jazz Pharmaceuticals Chiyoda, 日本 フルタイム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 ...
-
Pfizer Tokyo, 日本 フルタイムSpecialty Care Medical Affairs Lead, Japan · Position Purpose · Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. In th ...
-
Pfizer Tokyo, 日本 フルタイムROLE SUMMARY · The Senior Director Public Affairs Japan is responsible for leading the Public Affairs function in Japan. This is a high-profile position, supporting Pfizer Japan's business leaders as well as C-suite executives. The role will provide strategic public affairs and ...
-
Edwards Lifesciences Tokyo, 日本 フルタイムRole Purpose: · This position will drive the execution of Market Access strategies specific to the Edwards' BU portfolio of innovative therapeutic solutions for structural heart disease and/or advanced critical care technologies in Japan. · The successful candidate will drive sy ...
-
Alexion Pharmaceuticals Tokyo, 日本 フルタイムThis is what you will do: · Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the ...
-
Gilead Sciences K.K. Tokyo, 日本 フルタイムDescription · Specific Responsibilities: · Essential Functions: · Medical Affairs, eMS, Oncology · Specialty: Oncology · Specific Job Requirements · ・This position reports to the Oncology Associate Director or Director, reporting to the head of Oncology Medical Affairs in J ...
-
Edelman Tokyo, 日本 フルタイムEdelman Global Advisory is a newly launched standalone international advisory firm within the Edelman network that owns the firm's public affairs work. We have rebranded public affairs to advisory to better capture the evolution and future of this sector. Advisory service, among ...
-
Expedia Group Tokyo, 日本 フルタイムSenior Manager, Government & Corporate Affairs (Japan & Taiwan) · A unique opportunity to join a major game-changer in the online ecommerce space with great consumer brands and technology, with ambitious growth plans for the Asia Pacific region. We are looking for a Senior Manage ...
-
Guerbet Tokyo, 日本 Long-term/regularDescription · 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 ...
-
Abbott Tokyo, 日本Primary Function · The Structural Intervention (SI) Product Manager owns the SI portfolio in Japan. She/he is responsible for setting strategic direction in Japan for the CHD and Stroke privention portfolio and for tactical implementation of activities aligned to a patient-cen ...
-
Lime Tokyo, 日本 フルタイム - Salary /Lime is the world's largest shared electric vehicle company. We're on a mission to build a future where transportation is shared, affordable and carbon-free. Our electric bikes and scooters have powered 400+ million rides in 250+ cities on 5 continents, replacing an estimated 100 ...
-
Abbott Laboratories Tokyo, 日本 OTHERAbbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmac ...
-
Dexcom Tokyo, 日本About Dexcom · Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming di ...
-
Amazon Japan G.K. Tokyo, 日本 フルタイムThe opportunity to strike smart and innovative deals that shape the future of movies and television is here. · Amazon MGM Studios is the original movies and television development and production arm of Amazon. It is our role to produce original content for Amazon's Prime Video c ...
-
eMS, Medical Affairs
1週間前
Gilead Sciences, Inc. Tokyo, 日本 Paid WorkFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – workin ...
-
Alexion Pharmaceuticals Tokyo, 日本 フルタイムThis is what you will do: · The Patient Program Manager will report to the Patient Program Lead and will be responsible for the creation and management of patient and family materials for rare disease patients and families in the Japan Medical Affairs Division, as well as the op ...
-
OpenAI Tokyo, 日本 フルタイムAbout the Team · OpenAI's mission is to ensure that general-purpose artificial intelligence benefits all of humanity. · Our Communications team includes PR/media relations, employee communications, events, design, and other external-facing functions. This team's ethos is to supp ...
Associate Director, Regulatory Affairs Japan - Tokyo, 日本 - BioMarin
説明
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 Temporary
Exempt Non-Exempt
SUMMARY DESCRIPTION
State the overall function or purpose of the job.
We are seeking a highly motivated, energetic professional capable of working effectively in fast-paced environment to join our International Regulatory Affairs team.This position will be responsible for developing the strategy, preparation and execution of regulatory submissions (marketing applications (MAs) and post-marketing maintenance) for BioMarin products,interfacing with the Japanese regulatory authorities (MHLW and/or PMDA), and for providing insight and supportfor clinical developmentin Japan.Thispositionisbased in theTokyo office.
RESPONSIBILITIES
List the major responsibilities of the job.
Develop Japanese Regulatory filing strategies and identify risks and potential gating factors. Play an active role inleading the strategic planning and preparation of complex submissions including but not limited to the following: JNDA/JsNDA (content development, assembly of the dossier, submission, through approval); post-marketing maintenance including re-examinations, ; JAN applications, expedited pathway applications and any other required submissions in Japan. Must ensure all submissions are prepared in accordance with JP regulations. Serve as primary liaison with the Regulatory authorities (e.g., MHLW and/or PMDA) and interface on behalf of BioMarin to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Leadin preparation for and execution of Agency meetings.
Actively participate in multi-functional global team environment, and interface closely with U.S. and other global BioMarin offices to align on operational and strategic deliverables.
Evaluate new and emerging regulations/guidance to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin's productsor plans.
EDUCATION
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
A bachelor of science degree in a life science.
Qualified Pharmacistis required.
Fluent in Japanese and English.
EXPERIENCE
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Minimum of tenyears of industry experience with at least eightyears of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of theJapanese regulatory environment.
Proven track record for preparing, submitting, and gaining approvals for JNDAs.
The candidate is expected to have a thorough understanding of relevant drug developmentregulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
Proficiency with computer and standard software programs is required. Candidate must be fluent in English, both verbal and written (technical).Strong collaborative skills are needed as this position requires close working relationships with stakeholders both inside and outside of the company. Excellent verbal, written and presentation skills are also required.
CONTACTS
List the key positions, internal and external, with which the job incumbent must interact.
The candidate must interact with Japanteam members, International team members, and colleagues based in the global company headquarters.
BioMarin is Headquartered in California.
The position will report directly to the Head of APACRegulatory Affairs based in Tokyo.
SUPERVISOR RESPONSIBILITY
List the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a "dotted-line" basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
No directreports.
