Job Description グローバル研究開発本部 薬事領域スタッフとして、バイオ医薬品・ワクチンの新薬の開発開始から承認申請及び承認取得、並びに剤形追加及び変更管理に至るまでのCMC薬事業務に貢献していただける担当者を求めています。最先端のCMC技術を取り入れた製品開発や、製薬業界において注目されているCMC薬事関連トピックの協議に最前線で関与できる幅広い機会があります。 米国本社等のCMC薬事担当者と協働し、担当品のCMC開発ステージを適正に前進させ、論理的で科学的に質の高い承認申請資料のCMCパート(製造方法、規格及び試験方法、並びに安定性等)を作成する。 製品に関するCMC上の問題
Work Location Assignment: Mexico City, Mexico. Must be able to work from assigned Pfizer office 3 days per week, or as needed by the business. JOB SUMMARY Lead, manage and provide strategic direction to their regulatory team in assigned markets. Manage assigned projects at a cluster level; provide s
Job Overview: Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable. Summary of Responsibilities: These statements are intended to describe the general
Career CategoryRegulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of
Career CategoryRegulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of
Primary City/State:Mesa, Arizona Department Name: Regulatory Readiness-Corp Work Shift: Day Job Category:Risk, Quality and Safety Innovation and highly trained staff. Banner Health recently earned Great Place To Work® Certification™. This recognition reflects our investment in workplace excellence a
About This Position This position is responsible for planning, developing, and implementing Austin Energy's strategic plans and policies related to regulation of the electric utility industry in Texas. Job Description: Duties, Functions and Responsibilities: Essential duties and functions, pursuant
Job TitleRegulatory Affairs Manager Job Description Job Title Regulatory Affairs Manager ポジション概要 フィリップスの医療機器事業において、Hospital Patient Monitoring(HPM) および Sleep & Respiratory Care(SRC) 領域の新製品導入および既存製品の許認可維持を担うポジションです。 また、AIを活用したプロセス改善・業務変革の推進にも携わり、日本国内のみならずグローバルチームと連携しながら、Patient Safety & Quality(PSQ)全
As one of the world’s leading independent global investment firms, Invesco is dedicated to rethinking possibilities for our clients. By delivering the combined power of our distinctive investment management capabilities, we provide a wide range of investment strategies and vehicles to our clients ar
At HDR, our employee-owners are fully engaged in creating a welcoming environment where each of us is valued and respected, a place where everyone is empowered to bring their authentic selves and novel ideas to work every day. As we foster a culture of inclusion throughout our company and within our
Career CategoryRegulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how
Job Description Position Overview Independently manage projects of pipeline products and registered products, include but not limit to CTA, NDA, Renewal, Variations and related regulatory agency interactions. Achieve regulatory milestones within company determined timeline. Communicate with global R
SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars. ENVIRONMENTAL REGUL
Capital Markets Regulatory Change – Consultant / Senior ConsultantLocation: Dallas, Texas (Hybrid) | Practice Area: Capital Markets | Type: Permanent Deliver regulatory transformation that helps financial institutions navigate complexity with confidence. The RoleAs a Consultant or Senior Consultant
Job Overview: Responsible for responsible for managing laboratory instruments, ensuring compliance with regulatory standards, and supporting quality and validation activities in a cGMP environment. Summary of Responsibilities: Manage the entire lifecycle of laboratory instruments, including installa
CAPCO POLAND *We are looking for Poland based candidate. This role is hybrid. At Capco Poland, we’re not just another consultancy - we’re the spark behind digital transformation in the financial world. As a global leader in technology and management consulting, we thrive on helping clients tackle th
Resumen de descripción de puesto The Regulatory Operations job family involves roles responsible for handling the operational "back-office" aspects of regulatory submissions, such as dossier preparation, Clinical Trial Disclosure, submission management for all franchises, Submission publishing, lice
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
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how
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