and other presentations . About the Role Senior Manager, Global Regulatory Affairs Strategy As the Senior Manager, Global Regulatory... Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, you will provide regulatory strategy...
Job Description: Responsibilities Job Title: Regulatory Affairs Manager Reports to: (Acting) Director, Regulatory... Affairs FLSA Status: Exempt Job Summary Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Manager...
Responsibilities: The Regulatory Affairs Manager will draft and file documentation and submission materials for new...&D PPM (product and project manager) QA marketing commercial and other departments to integrate regulatory requirements...
The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval... on how best to interpret the regulatory legislation and guidelines. The Regulatory Affairs Nonclinical / Clinical team plays a key role...
Job Summary: The Manger of Regulatory Affairs is responsible for managing the regulatory and scientific aspects... pharmaceutical Regulatory Affairs experience (with combination product, clinical and CMC experience) Experience with administration...
+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related...Responsibilities: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments...
of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key... Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound...
. What you’ll be doing As a key member of the Nuvation Regulatory Affairs team, you will collaborate with a cross-functional team...-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission...
Job Description General Summary: Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion... (MRC), and act as Global Regulatory Affairs Advertising and Promotion (GRAAP) representative on cross-functional teams...
POSITION SUMMARY Position Title: Vice President, Regulatory Affairs Reports to: CMO Company Summary: Client...: This is a newly created full-time position to continue the development and lead Client's Regulatory Affairs capabilities. The Vice...
Job Title: Associate Director Global Regulatory Affairs Location: Cambridge, MA 02142 Duration: 06+ Months...: knowledge of US Regulatory Affairs Recommended experience: 0-3 years for Associate level, 4-7 years Intermediate level, and 8...
Job Description General Summary: The Medical Affairs Senior Director provides medical and scientific leadership... of Nephrology medical plans. Key Duties and Responsibilities: Develops medical affairs plans, including Launch and Life Cycle...
Job Description General Summary: The Medical Affairs Medical Director will provide medical leadership for T1D...-level critical thinking abilities are required. Key Duties and Responsibilities: Under direction of the Medical Affairs...
Job Description Director State Government Affairs will be responsible for developing and implementing the company...’s state/regional government affairs and public policy strategy. This position will work closely with several functional areas...
Job Description General Summary: The Medical Director, Medical Affairs Strategy will provide medical leadership... and Responsibilities: Develops medical affairs plans, including Launch and Life Cycle Management study plans Critically interprets...
Regulatory Affairs Advertising and Promotion representative on program and other cross-functional teams May serve as Chair... strategic and tactical regulatory support and guidance for assigned product and disease state communications for Vertex product...
practices in relation to regulatory standards and statutory requirements. Manage the review of pharmacy benefit manager... manager filings are properly reviewed and addressed within statutory and regulatory timeframes. Coordinate Pharmacy Benefit...
in knowledge of regulatory affairs, research ethics, and Responsible Conduct of Research (RCR) is preferred. Experience with basic... understanding of translational research principles and biobanking processes. Basic knowledge of regulatory affairs, research ethics...
and modest costs. Description of Role The Manager of Strategic Sourcing & Vendor Management, who will report to the Senior... CROs and vendors. Monitor supplier performance and compliance with finance, legal, quality, and regulatory. Drive...
Affairs, Regulatory, Legal, Compliance, Biostatistics, and external partners to ensure scientific accuracy and alignment... Job Description The Global Publication Manager is responsible for the strategic planning, development, and execution of global publication...