Regulatory Affairs Manager

The CompanyiNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.The OpportunityWe currently have an opportunity for a Regulatory Affairs Manager to join our Regulatory Affairs team on a full-time basis.Reporting to Japan Country Lead & Head of Compliance (Sokatsu), the position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and local activities in Japan.Key Accountabilities And Performance Indicators IncludeRegulatory Affairs (Yakuji)Submission of regulatory application documents of products & obtaining approvalsWrite, obtain, and maintain approvals for the Japanese market and plan the strategy.Plan submission schedule and monitor the status.Prepare import/reimbursement application documents and maintains the approvals.Collect information of new product under development.Managing post registration changes including regulatory submissionsCollect and assesses product change information to take necessary actions.Submit and obtains approvals of product variations to ensure up to date product complianceRA Document control & regulatory intelligenceMonitor and interpret updates to the Pharmaceutical and Medical Device Act (PMD Act) and related regulatory notices issued by MHLW and PMDA. Assesses their impact on iNova’s products and operations in Japan, provides strategic regulatory guidance, and implements appropriate risk mitigation measuresCollect information directly from the industry to secure company’s benefits.Support Innovation, BD and Commercial Expansion ProjectsSupport successful outcomes for innovation, BD activities and major commercial expansion projects by supporting regulatory due diligence, and the collation and dissemination of technical information including dossiers, product lists, formulations, and artworksEducation and training for development.Other projectsAlways support the local & global team whenever necessary.Other global, local and ad-hoc projects may be assigned.QualificationsBachelor’s Degree required.Pharmacist License welcomed but not required.Minimum 6 years of experience in regulatory affairs management in the pharmaceutical industry in Japan.Minimum of 2 years of people management experience and good pharmacological/ pharmaceutical/ clinical knowledge.Skills & ExperiencePharmacy, medical or relevant science degree with good pharmacological/ pharmaceutical chemistry/ clinical knowledge (Essential)Deep understanding of relevant regulatory requirements for medicines, medical devices, health foods, dietary supplements, cosmetics and veterinary medicines (Desirable)Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in Japan and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of iNova’s productsStrong project planning and organisational skills and a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range of health care productsUnderstanding of matrix organisational issue and ability to communicate to multiple stakeholders to facilitate achievement of key strategic objectivesDemonstrated strong interpersonal, communication and influencing skillsDemonstrated leadership skills; proven decision-maker, hands-on and action-oriented styleNative level Japanese language and business level English required.Personal AttributesAbility to work effectively within a team in a fast-paced environmentEstablish good working relationship with both internal and external partiesDemonstrate ability to handle multiple projectsStrong organizational, planning and follow-up skillsGood IT skill is an added advantage but not mandatoryProficient in Microsoft OfficeHigh level of attention to details and accuracyStrong communication skills (both oral and written) and time-management skillsAble to interact with internal and external stakeholders in a professional mannerSelf-motivated, able to prioritize, multi-task and meets deadline in a timely mannerPositive, proactive attitude and a keen learnerProven track record of developing people with specific focus on ambition and passionHigh capability in delivering results among strategy changes and transformationsDecisive, self-motivated