CMC Dossier Lead AI-Driven Regulatory Strategy
Initial Therapeutics, Inc.
Initial Therapeutics, Inc. is seeking a CMC dossier leader to manage and coordinate CMC dossier preparation for regulatory submissions. This role demands strong knowledge in pharmaceutical development and experience in authoring CMC dossiers. You will work in Framingham, MA, leveraging cutting-edge tools to support Sanofi’s innovative pipeline. Enjoy competitive benefits, a diverse work environment, and the opportunity to significantly impact drug development. #J-18808-Ljbffr
- ...progress. Join our CMC dossier Sciences team as... ...digital tools and AI‑powered solutions... ...Information We’re an R&D‑driven, AI‑powered... ...Responsibilities Lead, coordinate, and manage... ...between dossier strategy and CMC activities... ...of CMC dossier for regulatory submissions (IND/...Regulatory
- ...Massachusetts, is seeking a professional to lead the preparation and development of CMC dossiers to support timely regulatory submissions. The ideal candidate will possess... ...development. The role involves driving CMC strategy alignment, managing submission teams, and leveraging...Regulatory
$148.5k - $214.5k
...Mass Digital Health is seeking a Regulatory Affairs CMC Project Lead to guide cross-functional pharmaceutical... ...minimum of 6+ years of CMC regulatory strategy experience, you will coordinate regulatory... ...while working with advanced AI technologies in a dynamic environment...Regulatory- ...Mass Digital Health is seeking a Global Regulatory Affairs CMC Lead to guide pharmaceutical and vaccine products through regulatory strategies. This role involves collaboration across R&D, Manufacturing, and Quality, driving success with health authorities like FDA and...Regulatory
- ...patients, accountable for impact, and committed to doing the right thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the U.S. across development, registration, and lifecycle...RegulatoryLocal area
- ...Main Responsibilities Lead, coordinate, and manage CMC dossier preparation and development... ...alignment between dossier strategy and CMC activities to support... ...of CMC dossiers for regulatory submissions (IND/IMPD/CTN... ...CMC dossier content. Drive AI-powered solutions and...Regulatory
$159k - $195k
...A leading biotechnology firm in Waltham, MA is seeking an Associate Director of Regulatory Chemistry Manufacturing and Control (CMC). This role involves executing global regulatory strategies and partnering with various teams to support clinical registration and commercial...Regulatory$122.25k - $176.58k
Job title: Global Regulatory Affairs (GRA) Chemistry, Manufacturing... ...and Controls (CMC) CMC Lead Location: Morristown,... ...meets bold, AI-powered research. In R... ...drive global regulatory strategies for pharmaceutical and... ...About Sanofi We’re an R&D‑driven, AI‑powered biopharma...RegulatoryWorldwideFlexible hours$207k - $253k
...Madrigalpharma in Waltham is looking for a Director, Regulatory Affairs CMC to drive regulatory strategies for clinical trials and market approvals. Key responsibilities include leading CMC regulatory dossier development and engaging with Health Authorities. The ideal...RegulatoryFull time- ...GlaxoSmithKline is seeking a Regulatory Affairs Lead to oversee CMC regulatory strategy for vaccine projects in the U.S. The role focuses on compliance with FDA regulations and includes responsibilities like preparing regulatory documents, mentoring teams, and driving...Regulatory
- ...Culture Modelling & AI Development Senior... ...passion for driving data‑driven decision‑making and... ...the modelling strategy across multiple... ...culture development. Lead AI solution development... .... Contribute to regulatory filings, technical documentation, and CMC packages, ensuring...Regulatory
$196k - $240k
...A biotechnology firm in Waltham, MA, is seeking a Director of Regulatory Affairs – CMC. This strategic role includes leading global regulatory strategies and mentoring team members. Candidates should have 10+ years of experience in biotech/pharmaceutical industries and...Regulatory- ...Madrigal, a biopharmaceutical company in Waltham, MA, seeks a strategic leader for regulatory CMC activities. The role involves developing regulatory strategies, guiding teams, and interfacing with Health Authorities. The ideal candidate possesses a BS in life sciences...Regulatory
$185k - $210k
...Job Description The US Regulatory Strategy Lead is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed... ...project teams, representing Regulatory on an agenda‑driven basis. The lead presents the US regulatory position on assigned...RegulatoryOdd jobTemporary work- ...Job Title: CMC Project Leader Location... ...the CMC Project Lead within our Cluster... ...deepimmunosciencemeets bold, AI-powered research.... ...We’re an R&D-driven, AI-powered... ..., Quality, Regulatory CMC, CMC Dossiers, Project Management... ...overall project strategy and execution of...Regulatory
- ...Massachusetts Nonprofit Network is seeking a Director of Technology Strategy & Operations to enhance organizational efficiency through... ...and managing teams. Strong leadership skills and a focus on data-driven decision-making are essential for success. The organization...
- ...Staples Canada is looking for an Associate Manager, Promotional Strategy at its Framingham location. This pivotal role will drive promotional strategies across stores and online channels, combining data insights with business acumen. As part of the Omni Portfolio team...
- ...Sobi, located in Waltham, Massachusetts, is seeking a US Regulatory Strategy Lead responsible for developing and implementing US regulatory strategies for both development and marketed products. You will partner with global teams ensuring effective communication and collaboration...Regulatory
- ...develop new business opportunities in Waltham, Massachusetts. The role involves managing customer relationships, driving sales strategies using AI-driven tools, and collaborating effectively with teams to achieve objectives. A Bachelor’s degree and experience in sales or...
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations... ...shared purpose: leading the fight against... ...). Our success is driven by our people. We... ...strengthening our workforce strategy to ensure we have... ...regulatory CMC leadership to support... ...CMC regulatory dossier content and then reviews...RegulatoryMinimum wageFull timeLocal areaFlexible hours- ...Description Job Description: Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various... ...applications. Support regulatory activities for the strategies aligned with Health Authority requirements...RegulatoryImmediate start
- ...Sobi - Swedish Orphan Biovitrum AB (publ) is seeking a US Regulatory Strategy Lead responsible for developing and implementing regulatory strategies for their products in the US market. This pivotal role involves leading interactions with the FDA, preparing teams for...Regulatory
$159k - $195k
...living with genetically driven neuromuscular diseases.... ...The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing... ...global CMC regulatory strategies for our programs in... ...Primary Responsibilities Lead CMCRegulatory execution...RegulatoryLocal area$196k - $240k
...living with genetically driven neuromuscular diseases.... ...Summary The Director, Regulatory Affairs – Chemistry, Manufacturing... ..., and Controls (CMC) is responsible for... ...global CMC regulatory strategies for Dyne programs across... ...Leadership & Program Ownership Lead and execute global CMC...RegulatoryLocal areaWorldwide$207k - $253k
...strategic, tactical and operational regulatory CMC leadership to support... ...Independently develop and lead execution of regulatory CMC... ...registration and/or post‑approval strategies for assigned products. Apply... ...strategy for CMC regulatory dossier content and review this...RegulatoryFull timeFlexible hours$128.9k - $226.05k
...Lead Technical Product Manager – UpToDate Growth Locations: Waltham... ...expertise with responsible AI to build products that improve... .... Key Responsibilities Growth Strategy & Expansion Define and drive a... ...required for clinical, privacy, and regulatory environments. User Insight &...Regulatory$148.5k - $214.5k
Job title: Regulatory Affairs CMC Project Lead Location: Morristown, NJ About the job As Regulatory Affairs... ...multiple projects, leveraging AI and digital platforms to accelerate... ...manufacturing to develop regulatory strategies that navigate complex global requirements...Regulatory- ...the Workhuman Blog and Resource Library. The ideal candidate will manage the blog, mentor writers, and set editorial strategy while leveraging data-driven insights. With 6-8+ years in content strategy or editorial roles, you will enhance the blog’s engagement and impact...3 days per week
$180k - $220k
...A leading life sciences consulting firm is seeking an Associate Director, AI Solutions, to lead AI and data strategy engagements in the U.S. This role involves collaborating with offshore teams, managing senior relationships, and mentoring. The ideal candidate will have...$330k - $365k
...vision is to build a world leading oncology company... ...You will own the medical strategy, lead study design and... ...and adherence to GCP and regulatory standards. Interpret and... ...program management and CMC to align program... ...Opportunity to join a mission‑driven team where you’ll...RegulatoryTemporary workFlexible hours
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