Job Description
The Position
The candidate will be a part of Japan Regulatory Affairs (RA) organization and reporting into the Head of Japan Regulatory Affairs.
Responsibilities:
Primary Activities:
Develops new drug regulatory strategy for Japan from early Phase to Life Cycle Management (LCM) activities (i.e.: new indications, line extension, major efficacy variations aligned with regional priorities
Collaborates with commercial and local stakeholders to align regional regulatory strategy with country priorities.
Communicates program information with Country team to facilitate developing local regulatory strategy. Identifies the best possible regulatory strategy options in discussion with the countries for filing and pre-submission requirements/support needed from global teams.
Primary communicator with Regulatory Franchise and Global product strategy team members on key strategic issues (including updated guidelines/requirements) for Japan / regional countries and ensuring any updates are communicated in a timely manner.
Responsible for Labelling activities, such as development and maintenance of local labels, package inserts and Guide for Patients and artwork (AW).
Responsible as a point of contact to local Health Authority (PMDA)
Oversee external service providers.
This position needs communication and teamwork skill with responsible functions in local and global.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Other activities:
Be a SME for RA related system and/or procedures if required
Be a point of contact for RA/ORD related inquiry/communication from local HA and/or hospitals if required
Working in matrix environments including global teams
Required Education, Experience, and Skills:
Bachelor's degree and at least 15 years of pharmaceutical industry experiences including at least 3 years of directly related experience, OR
Master's degree and 10 years of pharmaceutical industry experiences including 3 years of directly related experience.
Thorough, knowledge of regulations pertaining to new drug registration and risk/ safety standards is a pre-requisite.
New Drug Strategy leadership is expected to have strong leadership, communication, decision making, and problem-solving skills.
Willing to perform labeling activities, even without prior experience in this area.
Japanese: Native level, English: Business level
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1-
Tokyo Organon Full time￥150,000 - ￥250,000 per yearWe are seeking an Associate Director to join our Japan Regulatory Affairs team. The successful candidate will be responsible for developing new drug regulatory strategy for Japan and collaborating with commercial and local stakeholders to align regional regulatory strategy with c ...
-
Tokyo Abbott Full time￥5,000,000 - ￥8,500,000 per yearSpecialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. · As th ...
-
Regulatory Project
4週間前
Tokyo Sanofi Full timeThe R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications. · ...
-
Japan ColgateSupports Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. Develops creative approaches and strategies to solve regulatory probl ...
-
Tokyo Abbott Laboratories Full timeSpecialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. · Direct development of product registration submission, progress reports, supplements, amendments or periodic experience reports. · Interact with regulatory agency to e ...
-
Tokyo Amgen Full time￥10,000,000 - ￥20,000,000 per yearThe Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen' ...
-
Head of Sales _ PEJ
1ヶ月前
Tokyo PharmaEssentia Corp. ￥10,000,000 - ￥20,000,000 per yearResponsible for leading and executing the sales strategy for the Japanese market, focusing on the commercialization of new drugs, market expansion, and revenue growth. · Minimum of 8 years of sales experience in the pharmaceutical or biopharmaceutical industry, with at least 3 ye ...
-
Tokyo ICON plc ￥800,000 - ￥1,200,000 per yearSenior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mis ...
-
Chiyoda myGwork - LGBTQ+ Business Community ￥1,300,000 - ￥1,800,000 per yearThis job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT) · Princ ...
-
Chiyoda Johnson & Johnson Innovative Medicine ￥1,200,000 - ￥2,500,000 per yearThe R&D Specialist/Manager is responsible for leading Japanese regulatory strategy and target labeling in J-CDT, sharing information with the Global Regulatory Team (GRT), and participating in GRT meetings to provide Japanese input. ...
-
Tokyo Alibaba Group ￥5,000,000 - ￥10,000,000 per yearThe Senior Manager, Government Affairs will report directly to the Vice President and Head of International Government Affairs for Alibaba. This newly created role will be based in Tokyo, Japan. The successful candidate will manage regulatory and political matters in Japan in are ...
-
Chiyoda Johnson & Johnson Innovative Medicine Full time$120,000 - $180,000 per yearLead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT). Prepare Common Technical Document (CTD) for Japan. Provide input on study design, conduct, and need for any additional studies for Japan. · ...
-
Tokyo Bora Pharmaceuticals ￥10,000,000 - ￥20,000,000 per yearWe are seeking a Senior Director of Business Development to drive sales growth for Bora's CDMO services, primarily in your designated region and secondarily in support of other global markets as needed. · Sales & Business Development · Market Strategy & Competitive Intelligence · ...
-
Tokyo Regeneron ￥1,200,000 - ￥3,000,000 per yearAs the Director of Medical Affairs Oncology in Japan, you will play a pivotal role in advancing our oncology assets and pipeline, · ...
-
Tokyo Alexion Pharmaceuticals, Inc. ￥2,000,000 - ￥2,800,000 per year+The Senior Manager Medical Science Liaison (MSL) will support medical and scientific objectives of Alexion's product/indication(s) across its life cycle. · +Develop peer-to-peer collaborations with Key Opinion Leaders (KOLs) · Serve as internal expert in therapeutic area demonst ...
-
Tokyo embecta ￥8,000,000 - ￥15,000,000 per year+ Job summary: Job Summary: · The Senior Manager of Quality will be responsible for assuring that the Japan region transition responsibilities conform to all applicable regulatory requirements. · + Qualifications:Provide overall leadership and management of the Japan Quality Mana ...
-
Tokyo Edelman ￥4,000,000 - ￥6,500,000 per year+ Job summary: Edelman seeks a Program Manager to join its Public & Government Affairs team in Japan. The successful candidate will be responsible for managing client relationships , developing strategies to promote clients' interests amidst geopolitical headwinds , and providing ...
-
Tokyo Celltrion Healthcare Co., Ltd. Full time￥4,320,000 - ￥6,480,000 per yearThe job involves regulatory affairs and quality assurance work for biopharmaceuticals including applications, document creation, and coordination. · Responsibilities include pharmaceutical applications, authority interactions, CTD and FD document creation, new product introductio ...
-
Tokyo AstraZeneca Full time￥6,000,000 - ￥12,000,000 per yearThe Senior Manager ,Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports medical · & scientific objectives of Alexion across product life cycle.Develops maintains peer-to-peer collaborations with KOLs under unbiased perspective,Engages phy ...
-
Tokyo Gilead SciencesWe'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 – working relentlessly to develop · therapies that help improve lives and to ensure access · to these therapies across the globe.W ...
-
Chiyoda Johnson & Johnson Innovative Medicine ￥4,500,000 - ￥6,500,000 per yearManagement of licenses for Marketing Authorization Holder (MAH), Management of Foreign Manufacturer Accreditation (FMA), Management of periodic Good Manufacturing Practice (GMP) inspection, Supports all regulatory activities associated with the registration and maintenance of app ...
