CMC Dossier Leader - AI-Driven Regulatory Lead
Sanofi
Sanofi in Framingham, MA seeks a CMC dossier leader to drive the preparation and submission of CMC dossiers for regulatory filings. You will lead cross‑functional teams, align dossier strategy with CMC activities, and ensure timely delivery using AI‑powered tools. The role requires deep CMC expertise, regulatory insight, and collaboration across R&D, GRA, and external partners to accelerate clinical development and market authorization. #J-18808-Ljbffr Sanofi
$148.5k - $214.5k
...Job title : CMC dossier leader ~ Location: Framingham, MA... ...edge digital tools and AI-powered solutions to transform... ...responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement... ...: We’re an R&D-driven, AI-powered biopharma...Regulatory$128.9k - $226.05k
...clinical expertise with responsible AI to build products that improve... ...full impact. We’re hiring a Lead Technical Product Manager to... ...functional role for a product leader who combines strong analytical... ...for clinical, privacy, and regulatory environments. User Insight & Market...Regulatory$330k - $365k
...are seeking a Medical Lead to provide clinical leadership... ...adherence to GCP and regulatory standards. Interpret... ...program management and CMC to align program... ...relationships with key opinion leaders, clinical investigators... ...to join a mission‑driven team where you'll contribute...RegulatoryTemporary workFlexible hours$207k - $253k
...connected by our shared purpose: leading the fight against MASH.... ...cirrhosis (F4c). Our success is driven by our people. We are... ...strategic, tactical and operational regulatory CMC leadership to support clinical... ...strategy for CMC regulatory dossier content and then reviews this...RegulatoryFull timeLocal areaFlexible hours- A leading product design company in Needham, Massachusetts is looking for a Senior Manager, CX Analytics. This role will spearhead data initiatives and develop scalable, AI-driven analytics to enhance customer experience operations. The ideal candidate has proven expertise...Suggested
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham... ...by our shared purpose: leading the fight against MASH.... ...(F4c). Our success is driven by our people. We are... ...operational regulatory CMC leadership to support... ...for CMC regulatory dossier content and then reviews...RegulatoryMinimum wageFull timeLocal areaFlexible hours$97.3k - $150.8k
...and documentation are complete and audit‑ready Create, analyze, and report on export compliance metrics and trends Monitor regulatory changes and lead targeted process or workflow improvements Minimum Qualifications A bachelor's degree and 6 years of professional work...RegulatoryWork experience placement$207k - $253k
...Key Responsibilities Independently develop and lead execution of regulatory CMC investigational, registration and/or post‑approval strategies for... ...commercialization. Define and drive strategy for CMC regulatory dossier content; review conformance with Health Authority...RegulatoryFull timeFlexible hours$196k - $240k
...living with genetically driven neuromuscular diseases.... ...Summary The Director, Regulatory Affairs – Chemistry, Manufacturing... ..., and Controls (CMC) defines and executes... ...Responsibilities Lead and execute global CMC... ...strategist and program leader, proactively identifying...RegulatoryLocal areaWorldwide$113k - $211k
Lead Technical Program Manager We are seeking a Lead Technical Program Manager to join our... ...ownership of outcomes, bringing a data‑driven and quality‑first mindset to decision‑making... ...and other technical domains. Exposure to AI/ML initiatives, data platforms, and DevSecOps...$159k - $195k
...living with genetically driven neuromuscular diseases.... ...The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing... ...Responsibilities Lead CMC regulatory execution... ...strategist and project leader for projects, providing...RegulatoryLocal area- ...The role involves using sophisticated analytical methods and leading laboratory projects to improve quality control processes. The... ...strong technical skills and work independently in compliance with regulatory standards while mentoring junior staff. A Bachelor's or Master...Regulatory
- ...Delivery Pathology Therapeutic Area Lead Join our dedicated Research... ...partners, competitors, and regulatory agencies. Essential Skills/... ...and failures along the way, driven by our shared belief in what... ...harnessing digital, data science & AI to fast-forward our research....RegulatoryWork at officeFlexible hours3 days per week
- ...enterprise data platforms, AI data architecture, data... ...ideal candidate is a self‑driven, collaborative, and deeply technical leader who thrives on partnering... ...data capabilities, and lead the end‑to‑end execution... ...teams to ensure adherence to regulatory standards and privacy...RegulatoryWork experience placementWork at officeFlexible hours
- SharkNinja seeks a Senior Manager, CX Analytics to lead our CX data capability and build AI-enabled analytics for global Customer Experience. You will partner with Enterprise Data to engineer data products, standardize metrics, and empower self-service analytics across...
- ...priorities into scalable talent solutions. You will partner with senior leaders to shape talent strategies and drive measurable outcomes across... ...programs, build scalable frameworks, and foster agile, data-driven approaches to development while maintaining strong stakeholder...
- Staples Advantage Canada in Framingham is seeking a Senior Manager AI Platforms to lead the evolution of its AI/ML platform capabilities. This critical role demands strong technical ability and collaboration across key departments to ensure scalable AI solutions. Responsibilities...
$77.2k - $95k
Acosta in Marlborough, Massachusetts is seeking a skilled Category Advisor to lead data-driven strategies that enable our sales team. This role involves managing space planning projects and training team members to ensure efficient operations. Ideal candidates will have...Work at office- MathWorks seeks a Senior Content Strategist to lead the Agentic AI content program. You will shape messaging, ensure clarity and reuse, and craft content for blogs, web pages, ebooks, and campaign materials. Coordinating with PMMs, product managers, SEO, and digital teams...
- ...of Excellence. This role demands 7-10 years experience in SEO and digital strategy, focusing on AI-driven search visibility and authority. Key responsibilities include leading the AEO strategy, analyzing consumer interactions with answer engines, and structuring content...Flexible hours
$90k - $180k
...because we believe multiple perspectives lead to more informed investment and business decisions... ...through cross‑platform, data‑driven projects and assignments. Responsibilities... ...support and guidance. Design and implement AI‑assisted intelligent tools to automate FIX...Remote workFlexible hours1 day per week- Staples Advantage Canada in Framingham, Massachusetts is looking for a Senior Manager, Regulatory Compliance to ensure products meet safety standards across North America. This role involves developing compliance strategies, interpreting regulations, and driving safety...Regulatory
- ...vision is to build a world leading oncology company... ...and adherence to GCP and regulatory standards. Interpret... ...program management and CMC to align program objectives... ...with key opinion leaders, clinical investigators... ...Opportunity to join a mission-driven team where you'll...RegulatoryTemporary workFlexible hours
- Staples is seeking a Senior Manager, Regulatory Compliance, based in Framingham, MA. This critical leader ensures our products meet regulatory and safety standards in North America. The successful candidate will monitor product compliance regulations, oversee compliance...Regulatory
$110k - $160k
A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over...Regulatory- Whole Foods Market in Dedham, MA is seeking a Team Member Leader to assist the Team Leader in daily operations, drive profitability, merchandising, and regulatory compliance. You will lead and develop Team Members, ensure health and safety standards, and promote company...Regulatory
- National Grid seeks a Lead Analyst for MA CIAC Policy & Procedure to provide technical leadership... ..., chair the MA CIAC committees, and drive regulatory activities, policy drafting, training, and knowledge management with AI-enabled tools. Role requires a Bachelor’s degree...Regulatory
- ...Principal Scientist - CMC Statistician Location:... ...immunoscience meets bold, AI-powered research. In R&... ...Sanofi We're an R&D-driven, AI-powered biopharma company... ...guidelines, and regulatory standards Serve as the... ...analyses for regulatory dossiers Why Choose Us Bring the...RegulatoryLocal area
$95k - $130k
...Heidelberg Engineering is seeking an experienced, hands-on Quality Lead to lead and own the company's Quality Management System (QMS)... ...with global QM while actively driving continuous improvement, regulatory readiness, and a culture of quality across the organization....RegulatoryFull timePart timeWork experience placementWork at office- 7-Eleven, Inc. is seeking a Store Manager to lead store operations with a focus on delivering exceptional customer service and maximizing profitability. You will supervise a team, drive merchandising initiatives, and ensure compliance with safety and company standards....
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