4 cnc operator jobs found

Biogen About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function: This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic alignment. Determines Submission Sciences support model and resource allocation. Supports IT initiatives including acquisitions, divestitures, software upgrades, and new software solutions Develop and...

Biogen About This Role: The Executive Assistant (EA)supportstwo executives: the VPforPharma CMC and Regulatoryand theVP for Biologics CMC Development & Regulatory.These leaders oversee global organizationscomprisedof both lab-based and office-based employees,operatingacross time zones and within highly technical development environments.This roleplays a pivotal role in ensuring the seamless operation of the leadership office. As a key member of the team, you will manage complex calendars, coordinate high-impact engagements, and foster proactive communication across the organization. This role requires exceptional organizational skills, discretion, and the ability tooperateindependently in a fast-paced environment. You will collaborate closely with the Strategy & Operations Lead to align priorities, support leadership forums, and drive strategic initiatives. Additionally, you will act asa central pointof contact for stakeholders across Biogen and externally, ensuring...

Biogen About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You'll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products. Primary duties include: Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority...

Biogen About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You'll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products. Primary duties include: Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority...