: Serves as the global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT.... Strong knowledge of global regulatory requirements for drugs and biologics. Ability to function as the lead interface with the US FDA...
will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure.... Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product...
of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Lead Oncology... where you will contribute to global regulatory team to develop strategies to maximize regulatory success towards achievement of program...
Job Title: Global Regulatory Lead Location: Bridgewater, NJ / Cambridge, MA (hybrid) About the Job: Are you ready... Team as Global Regulatory Lead and you’ll be responsible for the development & execution of global regulatory strategies...
(SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global...-Regulatory teams and be accountable to provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs...
Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs... operational support for assigned programs. How you will contribute Partnering with the program Global Regulatory Lead (GRL...
CMC regulatory objectives for one or more programs, lead the preparation and filing of regulatory CMC submissions... department/corporate objectives. Essential Functions: Lead the development of CMC regulatory strategy for assigned clinical...
Who we are looking for The Regulatory Exam Lead, Vice President, reports to the Global Head of Examination Management... for As Regulatory Exam Lead you will: Be responsible for examination planning and supporting pre-examination readiness exercises...
. Job Description The Senior Director, Global Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) Lead... in clinical development, program management, legal, regulatory, and commercial. As an essential part of this growing organization...
Contribute to the development and lead implementation of global go-to-market strategies, positioning, messaging, and marketing... regulatory requirements, reimbursement processes, and industry trends. Experience leading global device launches, from planning...
Job Title: Global Value and Access Lead, Oncology Location: Cambridge, MA About the Job This role is responsible... impact on millions of patients around the world. Main Responsibilities Lead the Global Oncology Market Access & Pricing...
mission. OBJECTIVES: The Oncology Global Translational Lead (GTL) role is an exciting opportunity within the growing..., Clinical Pharmacology, Companion Diagnostics, Global Regulatory Affairs, Biomarker Sciences and Technologies, Global Medical...
leadership skills? Then join us! We are hiring for a Senior Medical Director, Global Clinical Physician Lead for Multiple... understanding of the full drug development process. Global external awareness within the therapeutic area and global regulatory...
and regulatory risk. The SOC1 & Risk Program Lead will play an important role on this team, responsible for managing the day-to-day... function that partners with State Street Global Advisors business teams to properly identify, assess and manage operational...
Job Description About This Role: As a Therapeutic Area Lead within the Global Clinical Supply Chain team... planning, manufacturing, and global distribution of investigational products in compliance with GXP and regulatory standards...
Job Description About This Role: As a Therapeutic Area Lead within the Global Clinical Supply Chain team... planning, manufacturing, and global distribution of investigational products in compliance with GXP and regulatory standards...
The Global Medical Communications Lead, Dermatology is a key strategic partner of the Global Medical Affairs team... stakeholders, the Global Medical Communications Lead, Dermatology will: Be the key decision maker in asset level medical...
Director, Global Safety Lead Who we are: is a biopharmaceutical company that is fueled by connections. We thrive...: Agios Pharmaceuticals is searching for a dynamic Director, Global Safety Lead to join our Medical Safety and Risk Management...
Lead communications and serve as main contact with regulatory bodies Develop, review, and submit high-quality and timely...Job Title: Senior Regulatory Specialist Job Location: United States Job Location Type: Remote Job Contract...
Company Description Are you ready to trade your job for a journey? Become a FlyMate! Passion, excitement & global... where they are in the world. What more do we need to truly be unstoppable? Perhaps, that is you! Who we are: Flywire is a global...