Regulatory Submission Project Manager Jobs in Massachusetts

... The Biologics Specification Committee (BSC) Manager will own the specification business ... that supports GMP testing and regulatory submissions. This role is highly ... DS/DP, Manufacturing, Supply, Quality, and..

... commercial specifications, and defining the regulatory submission strategy. As a member of ... leads, global brand leads, technical project teams, and regulatory leads to generate and execute ... sciences..

... and transformative business results. Position: MANAGER – MANUFACTURING SCIENCES & TECHNOLOGY ... personal lives. POSITION SUMMARY: The manager in the Manufacturing Sciences and ... as technical lead and people..

... Reports to Director of RQA, Manager of RQA is a member ... studies) and clinical bioanalysis for regulatory submission that are executed in compliance ... compliance with international and..

... mastery of the fundamentals of regulatory affairs, the Associate Director will ... the Executive Director, Head of Regulatory Affairs, The Associate Director establishes ... Affairs, The Associate Director establishes..

... a well-organized, dynamic, highly motivated project manager to help us deliver on ... Anderson and the Sr. Lab Manager, the clinical research project manager will have responsibility for day-to-day..

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas ..

Business Title: Director Regulatory Affairs Strategy Requisition Number: 95285 ... is currently seeking a Director Regulatory Affairs Strategy in Customer & ... Sciences clients, primarily to the Regulatory Affairs function..

Regulatory Compliance Specialist IV The candidate ... existing audit compliance efforts and regulatory compliance obligations, and to support ... in alignment with industry and regulatory requirements and expectations. Creates and..

... objectives, sound research principles and regulatory requirements under the direction of ... at the BIDMC. The Senior Project Manager will oversee research study protocols ... and IPCAVD program. The..

Regulatory Compliance Specialist IV The candidate ... existing audit compliance efforts and regulatory compliance obligations, and to support ... in alignment with industry and regulatory requirements and expectations. Creates and..

Project manage, route and collate PADERs and annual reports for all GE Healthcare Pharmaceutical Diagnostics (PDx) products Support preparation of other US and Canada (USCAN) filings as needed With the broader ..

... commercial specifications, and defining the regulatory submission strategy. As a member of ... leads, global brand leads, technical project teams, and regulatory leads to generate and execute ... sciences..

nnnnnXenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients ..

Description The Director, Market Development provides support to assigned health plan and/or specialty companies relative to Medicare/Medicaid/TRICARE product implementation, operations, contract compliance, and federal contract application submissions. The Director, Market Development ..

... clinical studies in accordance with regulatory requirements, Good ClinicalPractice (GCP) guidelines ... under the leadership of theClinical Project Managers (CPM).• Be an Ipsen ... of essential studydocuments, such as..

Description The Director, Actuarial Risk and Compliance is responsible for the overall management and oversight of actuaries and/or support staff where activities are concerned with identifying and managing risks. Identifies and ..

Practice and Business Development Manager (Asset Management) The candidate will provide significant practice and business development support to the firm’s Asset Management (AM) Practice Group. Work closely with the AM group’s ..

... is seeking a Quality Control Manager for a position based at ... processes, internal policies, procedures, and regulatory requirements. The individual will lead ... and stability-related documentation (stability protocols,..

**PRINCIPAL REGULATORY AFFAIRS SPECIALIST - RENAL CARE ... that Change Lives** The **Principal Regulatory Affairs Specialist** provides regulatory support for new product development ... support for new product development submission..

... worldwide. Join Takeda as a Manager, GMA, Global Medical Evidence Operations ... external regional and country specific regulatory guidelines. May serve as the ... Coordinate with Pharmacovigilance, Quality and..

... to AI model validation and regulatory submission preparation, while maintaining proper study ... meet all IRB, legal, and regulatory mandates. Responsible for collecting data ... Provide support and execute..

Associate Athletic Director for Compliance & Student-Athlete Success Category: Administrators Department: Athletics Locations: Worcester, MA Posted: Jun 1, 2022 Closes: Open Until Filled Type: Full-time Position ID: 148349 Share About Assumption ..