Japan Regulatory Expert - Safety

ArisGlobal is a dynamic and growing global software company dedicated to serving the Life Sciences industry (pharmaceutical, biotechnology, and medical device) in the management of their clinical trials, drug safety, and regulatory information. By empowering life sciences organizations to deliver breakthroughs faster, our client has become an industry leader, currently providing our technology solutions to 40 of the top 50 Biopharmaceutical companies, 4 of the top 5 pharma organizations, and 9 government health authorities, including the FDA, Health Canada, and the NMPA. Our end-to-end drug development technology platform helps hundreds of pharmacovigilance teams worldwide save time and effort, ensure future-proof compliance, and unlock deep insights from safety data. More than just creating software to collect data, Our company has formed a solution that provides game-changing efficiency, compliance, speed, and safety with accuracy and precision.

 Our global team – located in major corners of the world – includes some of the industry’s leading authorities, subject matter experts, and experienced professionals in their respective areas of life sciences. All are focused on advancing our innovative and market-proven solutions and services. We are growing quickly and looking for people with the best blend of experience, knowledge, talent, and ambition to join our team. If you are committed to making a difference and have the skills and expertise to make things happen, then you should consider joining ArisGlobal.

GENERAL SUMMARY

ArisGlobal is looking for a strong Japan Regulations Expert and product owner to join a team delivering world-class pharmacovigilance (PV) software for the Life Sciences industry. We are seeking a detail-oriented individual who will work with product managers and engineering scrum teams. The ideal candidate will be a strong Japan/APAC PV regulations expert with strong Japan product owner/product management experience developing solutions for PV customers, breaking down requirements into epics and stories with strong English and Japanese communication skills. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Monitor PV regulations in Japan/APAC, review and understand PMDA Regulations and the Green Book, and draw on Safety experience to interpret the regulations, assess the impact of these regulations on the LifeSphere Safety products, and ensure that the product line delivers timely compliance to these regulations.
• Collaborate with customers, industry, and health authorities to harmonize interpretations of the regulations to drive product requirements using customer working groups and other customer/industry forums. 
• Be the subject matter expert on safety regulatory requirements in Japan/APAC for the internal cross-functional teams and external stakeholders. 
• Establish thought leadership regarding Safety regulations influencing industry and regulators.
• Maintain a register of the regulations monitored and track outcomes for internal and external audits.
• Collaborate with the cross-functional teams to disseminate information and enable understanding of new PV regulations, industry best practices, and changes to existing regulations. 
• Work with cross-organizational and cross-functional teams to prioritize, develop, and implement innovative product features timely and with quality to enable customers’ compliance with PV regulations and enable our customers to realize improved efficiencies. 
• Author Initiatives with clearly researched market problems regarding PV regulations and well-defined product requirements with personas, use cases, design briefs, epics, etc., using tools such as Aha, JIRA, and Confluence.
• Work with the product manager to align product strategy and translate product roadmap features into well-defined product requirements, including features, user stories, and acceptance test criteria.
• Work in an Agile environment and continuously review the business needs, refine priorities, outline milestones and deliverables, and identify opportunities and risks.

EDUCATION AND EXPERIENCE REQUIRED

• Minimum of 7 years of experience in Japan Pharmacovigilance with knowledge of affiliate management, general data entry conventions, data analysis, compliance monitoring, dictionary management, coding conventions, aggregate report planning preparations, and regulatory submissions (Japan procedures)
• Ability to read, understand, and interpret the Greenbook and the Regulations for Pharmaceutical and Medical Devices Agency (PMDA) for Medical Devices, Pharmaceuticals, Cosmetics - Cosmetics Product Registration Procedures, Biotech, Food, and Food Supplements. 
• Should have a robust techno-regulatory background – a good balance of systems knowledge, regulator expertise, and business acumen
• Ability to understand customers’ needs and business requirements and to put customers first in product decision-making.
• Proficient in conducting requirement-gathering workshops
• Proficient in triaging and prioritizing product defects and feature requests
• Proactive and fully accountable in managing a healthy product backlog regarding PV regulations.
• Excellent presentation and communication skills in both English and Japanese with the ability to engage, influence, and inspire partners and stakeholders to drive collaboration and alignment.
• A high degree of organization, individual initiative, and personal accountability.
• Native Japanese speaker with the ability to Read and Write Japanese. 
• JLPT certified – N1/N2/N3, if non-native Japanese.

PREFERRED EXPERIENCE

• Working in an agile development environment is preferred.
• Experience and working knowledge of a PV system such as Argus/ARISg/LSMV/Veeva to support technical/functional requirements and related integrations is preferred.