Senior Stability Lead, CMC Strategy & Regulatory Submissions
Initial Therapeutics, Inc.
Moderna is seeking a strong scientific and operational stability leader to design and manage stability studies, interpret data, and support shelf-life and regulatory submissions for development, clinical, or commercial programs. This onsite role is based at Moderna’s Technology Center campus in Norwood, MA, collaborating with Analytical Development, Quality, Regulatory, Clinical Supply, and other stake- holders to ensure compliant product control strategies and uninterrupted supply. #J-18808-Ljbffr Initial Therapeutics, Inc.
$130.8k - $209.4k
...scientific and operational stability leader to support stability strategy execution across... ..., and regulatory support for assigned... ...program-facing stability lead who partners closely... ...sections for regulatory submissions, responses, and... ...cross-functional CMC teams to align study...SeniorRegulatoryPermanent employmentWork at officeWork from home- ...seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities... ...product lifecycles and develop global strategies in alignment with business priorities.... ...and prepare CMC/Quality regulatory submissions with stakeholders to drive timely approvals...Regulatory
- Moderna is seeking aRegulatory CMC Senior Leader based in Norwood, MA... ...team of CMC experts overseeing regulatory correspondence and submissions. You will steer product strategy across portfolio and drive... ...quality CMC sections. You will lead interactions with health...SeniorRegulatory
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Regulatory$212k - $333.19k
...therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...combination product regulatory strategies particularly pertaining to the development... ...aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs...SeniorRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space, particularly...Regulatory
- ...seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities... ...product lifecycles, develop global CMC strategies, and guide product teams in preparing agency... ...and regulatory applications. The role leads interactions with health authorities,...Regulatory
$142.5k - $256.5k
...patients worldwide.As a stability leader, you will... ...stability strategies across a diverse mRNA... ...actionable program, regulatory, and supply... ...’ll Do:Define and lead phase-appropriate... ...supporting IND/CTA submissions, pivotal readiness... ...cross-functional CMC team structures.Experience...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...Regulatory
- ...seeking an Associate Director, Global Regulatory, CMC to coordinate CMC regulatory activities... ...lifecycles and to develop global strategies that align with business priorities. You... ...product teams, prepare CMC and Quality submissions, and manage multiple projects in a fast...Regulatory
$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...Regulatory- Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical... ...projects. This includes being a regulatory lead for change development projects, new... ...assessment, US, EU and international regulatory submissions, commercial support, manufacturing...SeniorRegulatory
$167k - $300.7k
...and experienced Director, CMC Stability to lead an end-to-end stability function... ...stability and shelf-life strategies, design stability studies... ...timely CMC decisions, regulatory filings, and product lifecycle... ..., stability forecasting, submission authoring, and responses...RegulatoryPermanent employmentFull timeWork at officeWork from home$130.8k - $209.4k
...Therapeutics, Inc. is seeking a Senior Manager for Analytical Sciences &... ...in Norwood, MA. The role involves leading analytical qualification and validation strategies for late-phase and commercial programs, providing regulatory submission support, and managing lifecycle strategies...SeniorRegulatory$137k - $215.27k
...is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices... ...With some supervision, leads the execution of regulatory... ...and/or post-approval strategies for assigned products.... ...of robust and accurate submissions.Develops constructive...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...for patients? This role leads high-impact programs... ...stage through BLA submission, ensuring an efficient route... ...objectives with clinical, CMC, safety and commercial strategies...SeniorRegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$121.6k - $194.5k
The RoleThe Senior Data Product Manager will own the... ...cases across Moderna's CMC organization. This role... ...process knowledge, data strategy, and applied AI, translating... ...aspired to build the leading mRNA technology... ...nature of the work and regulatory requirements, only individuals...SeniorRegulatoryPermanent employmentFull timeWork at officeWork from home$235k - $285k
...Management and Portfolio Strategy Job TypeFull-timeDescriptionWelcome... ...thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of a... ..., external partners, and regulatory authorities to ensure... ...stages with regulatory submission experience (IND/CTA, BLA/...SeniorRegulatoryTemporary workLocal area- Treeline in Watertown, MA is looking for a Senior Manager, Clinical Data Management who... ...with CROs, manage external vendors, and lead process optimization efforts. The ideal candidate... ...in oncology, and a solid grasp of regulatory guidelines. This role entails mentoring junior...SeniorRegulatory
$89.9k - $143.8k
...execution across CMC Development programs... ...planning, stability study management,... ...product development and regulatory decisions.What You... ...appropriate testing strategies, sample management... ...analytical operations.Lead efforts to... ...requirements supporting IND submissions and product...SeniorRegulatoryPermanent employmentFull timeWork at officeWork from home$212k - $333.19k
...patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...and ideas into actionable strategies. You will set global regulatory direction... ...manner.Accountable for US FDA submissions and approvals of project(s) of responsibility...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$136.51k - $204.77k
...Title: Associate Director, CMC Lead Introduction to role:... ...ready to lead early-stage CMC strategy that turns precision radioconjugate... .../IMPD Readiness: Lead CMC regulatory strategy; guide and... ...data packages for IND/IMPD submissions. API/Drug Product/Analytical...RegulatoryHourly payTemporary work$89.9k - $143.8k
...execution across CMC Development programs... ...planning, stability study management,... ...appropriate testing strategies, sample management... ...analytical operations. Lead efforts to integrate... ...programs, and regulatory requirements supporting IND submissions and product development...SeniorRegulatory$212k - $333.19k
...shine? Join us as a Senior Director, Global Program... ...defines the asset strategy and leads all development and LCM... ...driving regulatory approval as well as launch... ...large-scale Phase III/submission projects and global launch... ...Pharmaceutical Sciences (CMC) Subteam, etc. to the...SeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift- ...Pharmaceuticals in Boston is seeking a Senior Medical Director for Clinical... ...successful candidate will define and lead the clinical strategy for povetacicept in primary membranous... ...for efficient trial execution and regulatory submissions. Applicants should have...SeniorRegulatory
$175k - $195k
...Real Chemistry is looking for a Senior Group Director, Strategy to join our growing team! We are looking... ...Strategy Leadership & Delivery Lead the development of insight-driven communications... ...audiences, market dynamics, and regulatory considerations ~ Strong...SeniorRegulatoryFull timeWork experience placementWork at officeLocal areaRemote work2 days per week$235k - $335k
...is focused on building an industry-leading pipeline of oral small molecule... ...make an impact:Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the company... ...Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and...SeniorRegulatory$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and... ...office.Key Duties & Responsibilities:Leads the development of regulatory... ...Strategy Documents including for regulatory submission documents and Health Authority...SeniorRegulatoryFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$163.5k - $281.6k
...a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio.... ...including IND/CTA, BLA/MAA, and post-approval submissions.Lead and manage the preparation, authoring, and...SeniorRegulatoryFor contractorsWork at officeFlexible hours
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