, regulatory and PV Serve as point of contact/alliance manager for selected regulatory vendor(s) Plan and execute... content plans and submission timeline for regulatory submissions o Plan kick-off meetings and comment resolution meetings...
Summary The Senior Manager, Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Combination Products... of unique and technologically complex products. The Senior Manager will manage teams and complex projects for global CMC...
Job Description General Summary: The Regulatory Compliance Senior Manager works to provide compliance oversight..., guidance and direction to all relevant Regulatory Affairs functions, key stakeholders and leadership teams primarily through...
Job Description General Summary: The Chemistry Manufacturing Controls Senior Manager will participate in the..., Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field Typically...
Job Description General Summary: The Regulatory Strategy Senior Manager will be responsible for contributing... regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior...
, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems..., etc. Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations...
to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs...Job Description General Summary: The Senior Director, Regulatory Strategy, is a regulatory leader with expert...
Job Description: Project Manager – US Pain Medical Affairs Summary: We are seeking highly organized and detail... teams, including marketing, clinical development, and regulatory affairs, to align strategies and enhance collaboration...
build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology... team, you will report to the Head of Evidence Generation, Global Medical Affairs Oncology. You will work cross-functionally...
Senior Manager, Regulatory Operations Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Senior Manager of Regulatory Operations to join our growing...
at product-specific regional regulatory teams and senior labelling governance meetings. Works with Labeling Operations to ensure... Typically required 10 years of experience in regulatory affairs in the area of global labelling or related discipline or the...
understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related... strategy Advises cross-functional teams and senior management on regulatory risks, considerations, and strategies for program...
Senior Manager, Marketing Operations, will be responsible for operational leadership and coordination for the US Rare Bone..., Commercial Operations, Sales Operations, Medical, Regulatory Affairs, Legal, Compliance, etc.) to ensure coordinated execution...
. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Global... to keep abreast of industry advances in technologies affecting Clinical Operations, Clinical Supplies, Regulatory Affairs...
Job Description General Summary: The Advertising Promotion Senior Manager is responsible for providing regulatory... both independently and collaboratively across functions Pharmaceutical industry and Regulatory Affairs ad/promo experience Education...
of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager, Aggregate Safety... (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc.) contributing to aggregate safety reports...
and content in conjunction with Aveo Regulatory Affairs. Supporting clinical trial and commercial teams, both internal...JOB TITLE: Sr Manager, Pharmacovigilance Operations DATE PREPARED:9/23/2024 JOB SUMMARY: The Sr. Manager...
Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC and work with the GRA CMC organization... life-changing therapies to patients worldwide. Join Takeda as a Sr associate, Global Regulatory Affairs CMC Submission...
is looking for a Senior Airport Lead to join the Boston Airport team in a non-exempt capacity. The successful candidate will oversee... compliant with all regulatory requirements and quality standards Achieve absolute operational integrity with zero safety...
regulatory requirements. Therapeutic area is vascular (PVD, CAD, EP) and devices are stents, balloons, guidewires... Affairs. Support, update and maintain the Clinical Trial Management System application for clinical study execution...