TMF Director - Regulatory Readiness & Process Lead
$195k - $275kKymera Therapeutics
Kymera Therapeutics is seeking an experienced professional to lead TMF management and drive compliance within clinical trials. The ideal candidate will have over 10 years in the biotech industry and a robust track record in TMF management, ensuring readiness for regulatory inspections. The role demands strong leadership, experience in strategic process improvements, and collaboration across Clinical Operations and regulatory teams. The position offers a competitive salary range of $195,000 – $275,000 with additional benefits. #J-18808-Ljbffr
$109.2k - $174.6k
The Role: The Manager, TMF Sytems and Operations plays... ..., and compliant with regulatory and company standards.... ..., and inspection-ready data and documents throughout... ...executing operational processes, and assisting with system... ...studies.Serve as TMF Lead sitting on the clinical...SuggestedPermanent employmentFull timeWork experience placementWork at officeWork from home- ...programs for neurodegenerative diseases like Huntington’s and ALS. This remote position will lead quality assurance efforts while ensuring compliance with rigorous regulatory standards. The ideal candidate will have extensive GCP QA experience and the ability to influence...SuggestedRemote job
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available... ...to role: Are you ready to set the global regulatory... ...options for patients? This role leads high-impact programs across... ...overall drug/biologic development processes and strategies for high...SuggestedHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$100k - $179.08k
...design, delivery, and management, the data these processes produce and Artificial Intelligence as a competitive advantage, leading transformational change at the enterprise... ...Management (BIM for Owners)Data Management/Readiness StrategyData Science & Advanced...SuggestedFull timeFor contractorsRemote work- ...Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection... ...excellence to enhance processes. Report inspection... ...and Skills:Knowledge of regulatory requirements and... ...leanProven ability to lead improvement projects and...SuggestedFull timeSummer workRemote workFlexible hours2 days per week
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available... ...to role: Are you ready to set the global regulatory... ...global patient access? This role leads the strategy for our most visible... ...drug/biologic development processes and strategies for high...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$275k - $315k
...Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics... ...and internal quality and SOP requirements; maintain audit-ready regulatory documentation and inspection readiness....Full timeTemporary workWork at officeLocal area3 days per week$209.35k - $258.6k
Regulatory AffairsCambridge, MA • ID: 26R-19 • Full... ...you?Job Summary:The Director, Regulatory Affairs -... ...LeadershipDefine and lead global labeling strategy... ...execution of labeling processes, including document development... ..., and inspection readiness across labeling...Full timeWork at officeLocal areaRelocationFlexible hours$163.5k - $281.6k
.... If you’re driven by purpose and ready to bring your best to work that truly... ...highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC... ...improvement of internal regulatory CMC processes, standards, and templates.Manage external...For contractorsWork at officeFlexible hours$110k - $155k
...services.Job TitleOperational Readiness Manager - Project... ...Managerial role is responsible for leading a team and overseeing the execution... ...Readiness stage-gate processes and clearly articulate these... ...Life Sciences, Engineering, Regulatory or related discipline OR a combination...Full timeRemote workWork visa$212k - $333.19k
...understand that my employment application process with Takeda will commence and that... ...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...development through registration and launch readiness for high-impact oncology programs....Minimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...my employment application process with Takeda will commence and... ....Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre... ...safety, and inspection readiness.A key element of this role... ...Japan, China).ACCOUNTABILITIES Leads and develops a team of...Minimum wageTemporary workLocal areaRemote work$238k - $374k
...my employment application process with Takeda will commence and... ...worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug... ...China).How you will contribute:Leads and develops a team of... ...ensure compliant, inspection-ready processes and documentation...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- OverviewAlnylam is the world’s leading RNA interference (RNAi... ...development and regulatory footprint, Regulatory... ...efficiency.The Director, Regulatory Sciences Technology... ...Sciences business processes, proactively identifying... ...compliant, and audit-ready.· Drive adoption of...Full timeTemporary workLocal areaFlexible hours
$163.5k - $281.6k
...you’re driven by purpose and ready to bring your best to work that... ...comprehensive global regulatory CMC strategies for assigned gene... ...and post-approval submissions. Lead and manage the preparation, authoring... ...of internal regulatory CMC processes, standards, and templates....Full timeFor contractorsWork at officeFlexible hours$183.55k - $275.32k
...Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory... ...labeling documents. Lead regulatory strategy for advertising... ...development, and launch readiness. Act as a trusted advisor... ...improvement of review processes to enhance speed, clarity,...Temporary workLocal areaRemote workWork from homeFlexible hours3 days per week$242k - $313.5k
...developing and delivering category‑leading precision therapies to... .... Job Summary The Senior Director, Regulatory Affairs CMC – Biologics... ...collaborates closely with Process Development, Analytical Sciences... ...adequacy, and submission readiness. Tracks CMC regulatory deliverables...Local areaFlexible hours2 days per week$238k - $294k
...Sr. Director, Regulatory Labeling and Advertising Promotion About Genetix... ...Promotion (LAP) is responsible for leading global product labeling and... ...submissions. Governance, Process and Compliance Support or... ...review. Ensure inspection readiness and documentation...Full timeWork at officeFlexible hours3 days per week$210.9k - $316.3k
...chapter and join EMD Serono. Ready to explore, break barriers,... ..., compelling promotion. The Director, Advertising and Promotion serves... ...as the U.S. promotional regulatory lead for assigned products and is... ...advertising and promotion processes, standards, and standard operating...Work at officeFlexible hours3 days per week$204k - $245k
...we approach every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved... ...in supporting post‑approval submissions, inspection readiness, and ongoing compliance activities. This is a full‑...Full timeWork at officeFlexible hours3 days per week- ...Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the... ...completeness, and submission‑ready standards. CMC Regulatory... ...around manufacturing process changes, analytical method evolution... ...authorities, including leading internal team to identify and...Flexible hours
$200k - $240k
...Associate Director, Regulatory Affairs Operations At Merida Biosciences, we are pioneering true... ...excellence across regulatory processes, systems, and submission planning while... ...submission activities including document readiness, publishing, quality control, and electronic...Work at officeLocal area$181k - $288k
...TitleDirector, Quality & Regulatory- Mergers &... ...&A)Job DescriptionThe Director, Quality & Regulatory... ...continuity.Your Role:Lead end-to-end Quality & Regulatory... ...define ownership of QMS processes, product quality, and... ...management.Drive Day 1 readiness and Day 2 execution, partnering...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Abby Care is building the leading AI-native platform for family... ...monitoring to each state's regulatory framework — and serve as the... ...: Own licensure and survey readiness. Lead preparation, on-site execution... ...licensure, survey and audit processes, and Medicaid program...Full timeWork experience placement
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ....Key Duties & Responsibilities:Leads the development of regulatory strategy... ...efforts on existing department processes and strategies, providing recommendations...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$167k - $300.7k
...The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within... ...You’ll Do: Serve as global regulatory lead accountable for all regulatory aspects... ...through the clinical development processes.Conducts risks and gaps assessment and...Permanent employmentFull timeWork at officeWork from home$240k - $320k
...believe in our bold ambition to become the leading dermatology company in the world. With... ....The OpportunityThis role leads US regulatory policy and advocacy efforts to support the... ...of Therapeutic Area Regulatory Affairs processes by incorporating lessons learned from FDA...Full timeTemporary workWork experience placementWork at officeWorldwide- Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products... ...will be accountable for specific labeling business processes.Key Duties and Responsibilities:Ensures compliance with...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
$247.2k - $334.4k
The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient... ..., pharmacovigilance, inspection readiness, and human subject research protections... ...development of scalable policies, processes, templates, tools, and governance that...Full timeTemporary workLocal areaFlexible hours$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early... ...changes to documentation or processes, including SOPs for regulatory... ...research) including submission-ready formatting.Clear alignment with...Full timeTemporary workLocal areaFlexible hours2 days per week
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