Director, CMC Regulatory Operations & Submissions
BioSpace
Regeneron seeks a Director to lead the Regulatory Sciences team in Troy, NY, turning strategy into execution and building high‑performing processes. You will author and coordinate CMC regulatory submissions across modalities from IND/CTA to NDA/BLA and post‑approval lifecycle. The role emphasizes scaling team output, establishing metrics, mentoring staff, and aligning regulatory strategies with business goals while navigating FDA/EMA guidance across biologics, small molecules, and advanced #J-18808-Ljbffr BioSpace
- Regeneron Pharmaceuticals, Inc. is seeking a Director to join the Regulatory Sciences team in Troy, NY. The role focuses on turning strategy into execution, leading CMC regulatory submissions across modalities from IND/CTA through NDA/BLA and post-approval lifecycle. The...Operations
$147.8k - $338.4k
...serious diseases. We are seeking a Director to join our Regulatory Sciences team, to turn strategy into execution. Someone who is operationally minded, enjoys building and... ...responsible for authoring and coordinating CMC regulatory submissions across all modalities biologics,...OperationsMonday to FridayShift work$147.8k - $338.4k
...diseases. We are seeking a Director to join our Regulatory Sciences team, leading the... ...and execution of global CMC regulatory strategies across... ...timeliness of regulatory submissions — from first-in-human filings... ...Establish and track operational metrics such as cycle time...OperationsWorldwideMonday to FridayShift work- Regeneron is seeking a Director to lead the Regulatory Sciences team, overseeing global CMC regulatory strategies across modalities and managing submissions from IND/CTA through NDA/BLA and post-approval activities. You will oversee a team ensuring quality, timeliness,...Suggested
$145k - $165k
...to the Corporate Compliance Director. The Compliance Manager will... ...for managing the day-to-day operations of the company's compliance... ...Assist with review of quotes, submissions, and other documentation in... ...in Legal, IT, HR, Finance, Regulatory and other core functions in...OperationsRemote workFlexible hours- ...Greenway seeks a Finance Manager to oversee day-to-day financial operations for the Greenway Conservancy and related entities in Albany.... ...and external auditors. The role reports to the Executive Director, requires GAAP proficiency, and involves coordinating with the...Operations
$78k - $113k
...Department's training, professional standards, regulatory compliance, accreditation readiness,... ...improvement programs. Reporting to the Director of Public Safety, this position is... ...fostering a culture of accountability, operational excellence, and continuous improvement....OperationsFull timeFixed term contractWork at officeFlexible hours- Regeneron is seeking a Director of Manufacturing Compliance to lead the Fill/Finish compliance... .... This role interfaces with quality, regulatory, and governance bodies to sustain... ...and drive continuous improvement across operations. The position requires deep GMP expertise...Operations
- ...Driver Program. The role will ensure DMV compliance, supervise instructors, manage enrollment and records, and report on program operations with strict confidentiality and professional standards. The incumbent will collaborate with Hope House leadership, attend required...OperationsPart timeAfternoon shiftWeekday work
$172.2k - $286.9k
...with serious diseases. We are seeking a Director of Manufacturing Compliance who will be... ...Manufacturing and IOPS-level quality, regulatory, and governance bodies — representing the... ...inspection readiness of fill/finish operations. In a supporting and partnering capacity...OperationsMonday to Friday$146.3k - $306.4k
...Job Description As Director of Compliance & Property Management you will lead the administrative, governance, and regulatory management of Oracle Cloud Infrastructure’s growing... ...sites remain compliant, well-governed, operationally supportable, and positioned for...OperationsContract workTemporary workWork at officeLocal areaFlexible hours$200k - $333.4k
Director, External Manufacturing Compliance 3 days ago Be among the first 25 applicants... ...Manufacturing network in accordance with mandated regulatory requirements, Regeneron Quality Systems... ...and SOPs Leads and prioritizes operations and practices for supporting CMO and/or...OperationsContract work$145.5k - $205k
...currently an option. Who You Are The Associate Director, Corporate Compliance - Operations is an experienced compliance operations leader who combines... ...process performance, and addressing operational and regulatory challenges with thoughtful, practical solutions....OperationsFull timeWork at officeRemote work- Jones Lang LaSalle (JLL) in Albany, NY is seeking an experienced Facilities Manager to oversee multi-property facilities operations in the Capital Region. You will manage budgets, lead on-site staff, and coordinate with vendors to ensure safe, efficient building performance...Operations
- ...Life Sciences. We embed innovation, intelligence, and AI-native operations into the way the world designs, engineers, manufactures, and... ...Accenture is seeking a Manager to drive project execution in Digital CMC and PLM transformation work within our Supply Chain &...OperationsFull timeWork experience placementLive inWork at officeLocal area
- Pioneer Bank in Albany, NY is seeking an experienced Employee Benefits Operations Manager to lead the day-to-day workflows of the employee benefits division, ensure accurate processing of health and welfare plans, and maintain industry compliance. This full-time, exempt...OperationsFull timeMonday to Friday
$105k - $115k
...clear, concise reports and present findings and recommendations to senior management, supporting policy changes affecting compliance operations. Other reasonable duties as assigned. Functional and Supervisory Relationships Reports to the Chief Enterprise Risk Management...OperationsWork at office- ...judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation. Pursuant to the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair...OperationsLocal area
- ...Transformation, Digital/Data and AI, Cost and Productivity, with a focus on Aftermarket, Front Office, Supply Chain and Manufacturing Operations.Strategic Vision: Craft strategies and plans that support clients in realizing their vision, navigating competitive landscapes,...OperationsFull timeLive inWork at officeLocal areaWorldwide
- ...Life Sciences. We embed innovation, intelligence, and AI-native operations into the way the world designs, engineers, manufactures, and... ...enable AI-driven manufacturing use cases Understanding of GxP and regulatory considerations in pharma manufacturing, and how they shape...OperationsFull timeLive inWork at officeLocal area
$145.6k - $282.6k
Director, Pharmaceutical Manufacturing Supply Planning Join to apply... ...role within the Supply Chain operations of Regenerons pharmaceutical... ...adhering to industry-specific regulatory and compliance standards. As... ..., ensuring readiness across CMC, manufacturing, and distribution...OperationsFull timeLocal areaDay shift$139.53k - $157.04k
...InformationNY HELP: NoAgency: Teachers' Retirement SystemTitle: Assistant Director of Quality AssuranceOccupational Category: Administrative or... ...external customer service-Direct, coordinate, and monitor the operations of the department to ensure that employers and members receive...OperationsPermanent employmentFull timeWork at officeLocal areaRemote work- Regeneron is seeking a Director, Strategic Operations & Organizational Effectiveness to lead the enterprise operating system for strategy across the Industrial Operations and Product Supply organization. You will drive clarity, alignment, and cohesive execution by translating...Operations
$131k - $147k
Versant Health is seeking a Director - Configuration to provide strategic leadership for its benefit configuration and claims platform operations. This role requires a minimum of 10 years experience in healthcare benefit configuration and strong team leadership capabilities...Operations- ...together our capabilities across strategy, consulting, technology, operations, Song and Industry X with our deep industry expertise to... ...chain operations — while meeting the demands of patient safety, regulatory compliance, and an evolving global supply network. How do we...OperationsFull timeWork experience placementLive inWork at officeLocal area
$78.7k - $150.6k
...Chain team in Troy, New York. This role will lead end-to-end supply planning across advanced therapy modalities, ensuring seamless operations for innovative medicines. The ideal candidate will have at least 8 years of supply chain experience and a strong understanding of...Operations- ...an Assistant Center Manager for the UPK collaboration with the Rensselaer School District. The role includes supervising center operations and assigned staff, while ensuring compliance with Head Start and Day Care licensing requirements. The position requires a Bachelor...Operations
- ...unmatched experience and specialized skills across more than 40 industries, we offer Strategy and, Interactive, Technology, and Operations services, all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. Our 738,000 people...OperationsWork experience placementLive inWork at officeLocal area
- TOKYO ELECTRON AMERICA, INC. in Albany is seeking a Program Manager to join the Integration, Operations, and Major Programs group. You will partner with R&D and engineering teams to drive operational excellence, manage projects, and advance high-priority research initiatives...Operations
$142.6k - $261.5k
...opportunity Our objective is to provide clients with a unique business perspective on how to leverage SAP technology to improve their operations. This is rooted in EY’s SAP service line capabilities (Supply Chain, FICO, BPC, Data & Analytics, Customer, Tech/Arch and...OperationsSummer holidayFlexible hours
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