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...
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 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...
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...
on , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... and procedures. Analyzes and approves manufacturing change requests. Represents CMC regulatory affairs on teams such as the product...
and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy... groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities...
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...
in our office three days per week on average. The Sr. Manager, Regulatory CMC, is responsible for contributing to/assisting... and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for marketed products...
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...
Coordinator to join the Regulatory Affairs - CMC Team. Primary Responsibilities: The successful candidate will provide high...Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role) Proclinical is seeking a Project...
) Proclinical is seeking a Project Coordinator to join the Regulatory Affairs - CMC Team. Primary Responsibilities: The... Posting date: 23 Jan 2025 Reference: 63940 Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role...
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.... This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs...
of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the... preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics...