This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This position reports to the Functional Area Head, Global Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies, working closely with the cross functional teams to prepare, review and submit regulatory documents, manage documentation systems and maintain interactions with regulatory agencies. - Work with multidisciplinary teams to ensure the quality, content, timelines, format of regulatory submissions and comply with all applicable regulations and guidelines governing the development, marketing and distribution of product candidates. - Represent regulatory affairs at study teams; provide guidance and develop strategies to ensure timely submission and approval of study related documents including protocol, IB, DSUR, amendment, IMPD etc. - Manage CROs depending on project assignment. - Proactively reviews and interprets regulatory guidelines with respect to impact on development programs. - Support agency interactions, including appropriate documentation of interaction, decisions and outcomes; contribute to the development of meeting requests, briefing documents and other supporting material. - Archive management for related projects including submission archive and tracking submission/approval dates and Health Authorities correspondences. - Work collaboratively with Stakeholders and peers to align on priorities and support corporate and department strategic goals. Qualifications - Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred. - RAC certification or other equivalent is preferred. Requirements - Minimum Bachelor’s degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 2 years of regulatory submission experience for product(s) development in the US and/or EU. - Experience supporting clinical development teams in the metabolic disease space is preferred. - Experience from IND through to BLA (or NDA), across all disciplines (nonclinical, clinical, CMC), as well as supporting regulatory interactions. - Experience working in multi-culture/multi-countries environment is preferred. Skills - Knowledge and understanding of metabolic disease biology and translational research is required. - Knowledge of US and EU regulations for biosimilars and/or innovative medicines. - Excellent written and verbal communication skills. - Ability to work cross-functionally in a fast-paced and collaborative environment. - Strong attention to detail and problem-solving skills. - Proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).

• Assisting with the coordination of the 340B Drug Pricing Program for all qualified entities. • Reviewing operating and regulatory compliance procedures to ensure proper application of laws. • Conducting ongoing internal audit functions, data analysis, and operation review. • Developing systems and processes to limit program liabilities and provide proper audits. • Monitoring monthly and annual reports on 340B Program participation. • Performing monthly compliance audits of various pharmacies and patient eligibility. • Maintaining 340B Program software and responsible for daily maintenance of the Split Billing Software. • Assisting with reporting, data requests, and other inquiries.

• 適用となる法令、ガイドラインおよび業界ルール等(特に臨床研究法、倫理指針、売情報提供活動ガイドライン、公正競争規約、透明性ガイドライン、MA/MSLの基本的な考え方)、並びに社内ルールに基づき、各種企画審査を行い、必要な教育とアドバイスを提供する。 • リスク分析に基づく年間活動計画を作成し、モニタリングによる検証、対応策の実施・改善など、コンプライアンスのPDCAサイクルを回すことで、研究開発部門・メディカル部門のコンプライアンス遵守を支援する。 • 研究倫理委員会・利益相反委員会の事務局業務(外部委員の契約/報酬管理、計画書/同意説明文書の確認、会議運営/議事録作成、審査書類の保管、審査、 案件の管理等)を行う。 • メディカル部門の決裁規程及び決裁システムの管理・運営を行う。

**Responsibilities:** - Support all our critical day to day compliance responsibilities including IAR registrations, communication reviews, OBA’s and more. - Partner with assigned business partners to directly support their day to day activity, business initiatives and compliance needs. This could include marketing programs, product development, planning recommendations and introducing new member capabilities. - Act as a daily resource to the team on compliance questions and issues, and work with the team on ongoing needs and challenges. - Act as a key point of contact in supporting member issues so we can quickly manage any situation to do what is best for our members. - Support our ongoing regulatory filings (ADV’s are important) and member agreements. - Work with compliance partners and other outside resources we use to ensure we always have an up to date and forward looking program, and solve critical problems. - Support the onboarding of all new hires into our compliance program. - Proactively build out policies and procedures that meet the changing needs of our growing business.