Job Title: CMC Regulatory Affairs manager Job Location: Great Britain, United Kingdom Job Location Type: Remote..., we are looking for a talented CMC Project Manager. This position will occupy a key role supporting Chemistry, Manufacturing and Controls (CMC...
to achieve the next wave of breakthroughs. The Manager CMC Regulatory Affairs is responsible for CMC technical document review... teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory CMC technical writing objectives...
Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions... years of experience in CMC regulatory affairs Experience with biologics required, cellular therapy experience strongly...
Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions... years of experience in CMC regulatory affairs Experience with biologics required, cellular therapy experience strongly...
This is what you will do: Position Summary The Manager of Global Regulatory Affairs Chemistry, Manufacturing.... Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Present CMC...
Job Description: This role is considered Hybrid. Responsibilities: The Manager, Regulatory Affairs CMC... Development is responsible for implementation of the global regulatory CMC strategy for commercial programs. The Manager is a key...
Job Title: Senior Manager, Global Regulatory Affairs -CMC Job Location: Maryland, USA Job Location Type: Remote....) Novavax Regulatory Affairs team is hiring a Sr. Manager, CMC to lead and support key regulatory CMC activities. Essential...
information to support cross-functional stakeholders. Work collaboratively to support the Regulatory Affairs CMC team to meet... of more senior Regulatory Affairs CMC Systems professionals. Requirements: Should have familiarity with data entry into complex...
Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy..., clarity, and accuracy. Represent CMC regulatory affairs on product teams and in health authority interactions. Provide...
in FDA regulated industry. At least 3 years of experience in CMC regulatory affairs. Experience with biologics...Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post...
with collaborators, customers, and team members to prepare (write and/or review) high-quality CMC submissions that meet regulatory... objectives and relevant legislation. Proactively coordinate the regulatory CMC aspects of programs, providing mentorship...
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs... changes. Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal...
in FDA regulated industry. At least 3 years of experience in CMC regulatory affairs. Experience with biologics...Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post...
to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects.... Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up...
must be PST - West Coast California As a Senior Manager in the Regulatory CMC department this individual will be responsible.../accountable for: RESPONSIBILITIES Planning, preparation and submission of global regulatory CMC-related content pertaining...
) About the Role: Join our dynamic team at Neurocrine as a Senior Regulatory CMC Manager where you'll play a crucial role... in shaping the regulatory CMC strategy and driving the successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions...
Manager, Regulatory Affairs - CMC Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Manager of Regulatory Affairs - CMC to join our Regulatory Affairs...
compounds, with supervision. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs...Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These...
compounds, with supervision. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs...Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director..., Regulatory Affairs and is based in Morristown, New Jersey. RESPONSIBILITIES Primary responsibilities of this role include the...