[Innovative Medicine] R＆D, Principal Scientist, CMC Group, CMC Sciences, Regulatory Affairs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/TechnologyAll Job Posting Locations:Chiyoda, Tokyo, JapanJob Description:Position SummaryTo prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval.To conduct change control of approved products appropriately.Specific Tasks and Job DutiesManage Team managementFulfill CMC-RA responsibilities at team meetings and contribute to compound development / product lifecycle managementSupervises members, manage resources and timelines to deliver activities on schedule.CMC-RA strategy planning / alignmentIdentifies and inputs relevant Japan CMC regulatory information required to develop global CMC-RA strategy at the project initiation.Develop Japan CMC-RA NDA strategyAlign to the product’s global post-marketing regulatory strategy.CMC dossier managementCreates pre- / post- approval CMC dossiers including consultation documents.Ensure regulatory document compliance through appropriate document preparation including accurate writing, review, QC, and compliance checks.Reviews CMC documents prepared by team members and provides valuable input.Implement regulatory proceduresPrepares and answers to CMC questions from PMDA, and communicate directly with PMDA officials where necessary.Handles change control of approved productsCopes with GMP / compliance inspection by PMDAManagement of regulatory changes in JapanAssesses the impact of new / revised CMC regulations and implements necessary changesContribute through task force / external activitiesParticipates in task forces/initiatives, collaborating with team members, as well as global and cross functional stakeholders to achieve continuous improvement.Participates in external events or industry activities and makes a positive impact.Minimum QualificationExperience/KnowledgeAt least 7 years’ experience in CMC related area in pharmaceutical industryFamiliar with CMC regulatory notifications in JapanExperience of completing NDAs in Japan either independently as a CMC-RA representative or as a team leader or Experience in regulatory procedures in pharmaceutical research / CMC-related operationsSkills/CapabilitiesAbility to discuss CMC regulatory topics with global members in EnglishAble to build trust with others including global members and governmentAble to respect others and appropriately discuss and build consensus with team membersAdaptability to IT/DXQualification/CertificateBachelor, Master, Doctor of Science degree＜ For Internal Applicants ＞If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.Once you move to 1st interview stage, please make sure to inform to your current manager.For Employee Referral Program (ERP), please read and understand the details of “Employee Referral Program” in Ask GS and make a compliant referral.Based on your experience and interview evaluation, the position title and level may vary.Required Skills: Preferred Skills:Benchmarking, Coaching, Consulting, Corporate Governance, Critical Thinking, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Organizing, Public Policies, Regulatory Compliance, Regulatory Development, Scientific Research, Strategic Thinking, Subject Matter Experts (SME) Collaboration, Technical Writing