Job Description Summary
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Position Overview: Sr. Associate Specialist is responsible for all RA tasks of own modality with supervision by the direct manager or project leader. Report to direct manager or to project leader or to core-team co-workers about submission projects status when it's requested. This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.
Key Responsibilities:
- Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
- Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
- Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
- Assesses changes in existing products to and determines the need for new /revise licenses or registrations.
- Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
- Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
- Contributes to writing and editing technical documents.
- Assesses adverse events through approved license dossier to support Safety Management Team.
- Understands and applies regulatory requirements and their impacts for submissions. (Monitor new/revised requirements and investigate the impact to Japan registration. Triage entry and to be Subject Matter Expert as required.
- Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions (Access to multiple sources to get necessary information with clear objectives and strategies.)
- Ensures compliance with pre- and post-market product approval requirements. (Lead communication with authorities as necessary with detailed supervision of direct manager or project leader.)
- Supports regulatory inspections as required. (Support direct manager to have internal and external audit.)
- Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Experience Requirements:
- A min. of 3 years experiences to handle product registration project as an independent Regulatory Affairs professional is prefered.
- QA/Safety Management experience is also preferred.
- Advanced level Japanese language skill to understand regulatory documents and to generate high quality submission package.
- Business level English (writing, reading, speaking) is required.
- Proven interpersonal skills and ability to communicate effectively with regulators, colleagues and business partners.
- Professional judgment and ability to operate with some autonomy, seeking senior guidance when necessary.
- Flexibility to adapt to different & unique process and cultures in new working environment. Especially, sharing mind, and motivation to contribute for team, are preferred.
- Applicants without prior experience in Regulatory Affairs must have experience in proactively communicating (including reporting, informing, and consulting) with supervisors and colleagues in a remote work environment, and be capable of independently and responsibly managing their tasks.
Required Behaviors:
- Servant Leadership:
- Prioritize team and organizational needs.
- Foster a supportive and collaborative environment.
- Actively listen and provide constructive feedback.
- Mentor colleagues and lead by example.
- Growth Mindset:
- Embrace challenges and view them as growth opportunities.
- Learn from setbacks and seek continuous development.
- Encourage innovation and creative problem-solving.
- Lean Mindset:
- Deliver value efficiently and eliminate waste.
- Continuously improve operations using data-driven decisions.
- Promote accountability and responsibility.
- Inclusive Leadership:
- Value diverse perspectives and create an inclusive environment.
- Seek input from diverse voices and challenge biases.
- Foster equity and inclusion.
- Empower Entrepreneurial Spirit:
- Encourage initiative and ownership.
- Support risk-taking and experimentation.
- Provide resources for innovative ideas and recognize efforts.
This role is ideal for an individual contributor with a strong background in regulatory affairs, who can provide strategic direction and ensure compliance with healthcare industry standards while embodying our cultural operating principles. If you have the expertise and are ready to make an impact, we encourage you to apply.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-FD1
Additional Information
Relocation Assistance Provided: No
-
Hino, Tokyo GE HealthCare ￥4,000,000 - ￥8,000,000 per yearProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Impacts quality of own w ...
-
Hino GE HealthCare ￥6,000,000 - ￥12,000,000 per year- Provides regulatory strategy and direction to business regarding healthcare industry regulations. · - Impacts quality of own work & team's quality of work. · - Develops regulatory strategies for product development. · - Works with cross-functional teams to prepare & submit regu ...
-
Hino GE HealthCare Full time￥6,000,000 - ￥12,000,000 per yearProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Impacts quality of own w ...
-
Yokohama GE HealthCare ￥6,000,000 - ￥12,000,000 per yearProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. · Provides regulatory in ...
-
Hachioji, Tokyo Agilent Technologies ￥2,000,000 - ￥2,500,000 per yearWe are seeking a strategic and results-driven Market Development Specialist to join our team. In this pivotal role, you will be responsible for identifying growth opportunities, developing market strategies, and executing initiatives that align with our organizational goals. · Ma ...
-
Japan-Hachioji-shi Agilent Technologies ￥500,000 - ￥1,000,000 per yearWe are seeking a strategic and results-driven Market Development Specialist to join our team. · Excellent understanding of market trends in Biopharma, Pharma (incl. CDMOs), Academia/ Life Sciences, in Japan. · Proactive in exploring, collecting first-hand market information from ...
-
Hachioji Agilent Technologies ￥2,000,000 - ￥2,500,000 per yearWe are seeking a strategic and results-driven Market Development Specialist to join our team. In this pivotal role, you will be responsible for identifying growth opportunities, developing market strategies, and executing initiatives that align with our organizational goals. · Pr ...
-
Sagamihara Johnson & Johnson MedTech ￥90,000 - ￥120,000 per yearIn compliance with MHLW ordinance 169 Quality Management System, MHLW ordinance 135 Good Vigilance Practice, FDA European MDD/MDR & other International Regulations, · ...
-
Tokyo, Tokyo Amgen ￥1,500,000 - ￥2,500,000 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' ...
-
Japan - Tokyo Amgen ￥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' ...
-
Tokyo Planet PharmaResponsible for developing the regulatory strategy, preparation and execution of regulatory submissions for innovative products with various tactics to expedite product registrations. · Develop regulatory strategy, preparation and execution of regulatory submissions for innovativ ...
-
Tokyo, Tokyo Planet Pharma ￥4,000,000 - ￥8,000,000 per yearThe Senior Regulatory Affairs – CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market. · Author, review, and m ...
-
Minato AbbVie ￥1,200,000 - ￥3,600,000 per yearThe Head of Regulatory Affairs in Japan will act as the representative of the regulatory affairs organization to the Japan affiliate and be a member of AbbVie Management Team in Japan. · Accountable for day-to-day management of the regulatory team in Japan. · Develop and manage J ...
-
Japan - Tokyo Amgen ￥1,500,000 - ￥2,000,000 per yearThe Associate Director of Regulatory Affairs will oversee regulatory strategies and interactions with key agencies in Japan. · ...
-
Ebisu, Tokyo Teva Pharmaceuticals ￥4,320,000 - ￥6,480,000 per yearWho We Are · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Wor ...
-
Tokyo Planet PharmaThe opportunity to develop regulatory strategy, prepare and execute regulatory submissions for innovative products in Japan, with a strong understanding of local regulatory requirements and experience leading regulatory activities. · Create proactive and robust regulatory strateg ...
-
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' ...
-
Tokyo, Tokyo Johnson & Johnson Innovative Medicine ￥800,000 - ￥1,500,000 per yearThe Manager/Specialist of Medical Affairs, Hematology will be responsible for conducting Medical Affairs (MA) activities for the Janssen Hematology brands primarily focused on proper usage and value maximization. · Lead or support to develop and execute strategy and Medical Affai ...
-
Tokyo Mallinckrodt Pharmaceuticals ￥8,000,000 - ￥12,000,000 per yearSupports the Global Regulatory Lead in the development and execution of the regulatory strategy. Responsible for operational and tactical project management to ensure satisfactory completion of regulatory milestones. · Bachelor degree; preferably in a pharmacy, scientific or tech ...
-
Tokyo Organon Full time￥80,000 - ￥120,000 per yearThe Associate Principal Scientist, Regulatory CMC Japan will be accountable for assessment of changes for regulatory impact, development of Japan CMC strategy, preparation of CMC documentation and execution of post-approval CMC supplements and new product registrations for the en ...
-
Japan Colgate ￥5,000,000 - ￥10,000,000 per yearResponsible for supporting 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 solv ...
