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-LjbffrVacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the TMF Director - Regulatory Readiness & Process Lead in Boston, MA vacancy
- ...seeking an experienced Associate Director of Trial Master File Operations to oversee TMF activities across our oncology... ...operational excellence and inspection readiness. The ideal candidate will have... .... Join us to build scalable processes and drive improvements in a fast...Suggested
- ...Responsibilities: Real-time Inspection Readiness. Develop, manage and... ...Plans associated with regulatory filings and real-time inspection... ...at creating tools and processes for efficient execution. Proficient... ...Operating Procedures. Lead and assist with additional...SuggestedWork experience placement
Katalyst HealthCares & Life Sciences
Boston, MA2 days ago $184k - $210k
...Phase 3 results for our lead candidate, it’s an... ...Associate Director, Trial Master File (TMF) Operations to lead... ...Operations, Quality, Regulatory, IT, and external vendors... ...to ensure inspection readiness and operational excellence... ...build scalable processes that support a growing...SuggestedWork at office2 days per week3 days per weekCandel Therapeutics Inc.
Needham Heights, MA2 days ago$95k - $118k
...looking for a dedicated and passionate TMF Operations Lead to ensure our clinical trial documentation... ..., complete, and always inspection‑ready. You’ll be the go‑to TMF expert for our... ...escalating when needed. Contribute to SOPs, processes, and industry best practices. Ensure...SuggestedWork at officeRemote workFlexible hours$120k - $217.5k
...IT Asset Management Process Lead The IT Asset Management (ITAM) Process Lead governs... ...support operational efficiency and audit readiness. Serve as the primary point of contact... .... ~ Experience supporting audits, regulatory inquiries, or formal risk assessments....SuggestedTemporary workFlexible hoursState Street Corporation
Quincy, MA2 days ago- ...Therapeutics, Inc. is seeking an experienced Associate Director, Trial Master File Operations to lead TMF operations across oncology clinical programs. This... ...days in the Needham office, emphasizing inspection readiness and operational excellence. The ideal candidate has...Work at office
- ...Description JOB TITLE: Executive Director, Regulatory Operations and Submission... ...is accountable to build and lead a high‑performing Regulatory... ..., and tracking, document readiness and quality control,... ...accountable to establish operations process excellence, including SOPs/...
AVEO Oncology
Boston, MA9 days ago - ...Associate Director, Regulatory Operations - Boston, Massachusetts Opportunity... ...will be responsible for leading and supporting global regulatory... ...of eCTD submission-ready documents in line with regulatory... ...publishing standards and submission processes Identify and implement...Work at office
Vivid Resourcing
Boston, MA3 hours ago $211.85k - $317.78k
Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business... ...spirit and autonomy of a leading biotech. You’ll join an... ...difference in patients' lives. Ready to lead and inspire? Apply... ..., assessment and selection process and may be requested by...Hourly payTemporary workWork at office3 days per week$160k - $240k
...Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting... ...the preparation of eCTD submission-ready documents, coordinating across functions... ...enhance operational effectiveness and drive process improvements within the department...Work at officeRhythm Pharmaceuticals
Boston, MA17 days ago$140k - $175k
CAI in Boston, MA is seeking an Operational Readiness Project Manager to provide strategic leadership bridging mechanical completion and sustained operational performance. You will lead project teams to ensure world-class performance and achieve right-first-time metrics...Full time- ...High School. This role emphasizes enhancing student postsecondary readiness, coordinating school events, and managing data systems. The... ...supporting students and families through the college readiness process. Responsibilities include advising on college applications and...
- ...College, Career & School Operations Coordinator to support student readiness for college and career opportunities at Fenway High School in... ...include guiding students through the college application process, coordinating educational events, and building partnerships with...
$235k - $260k
...daily at bedtime. Our lead development program targets... ...experienced and strategic Senior Director of Regulatory Affairs Advertising/... ...to support product launch readiness and lifecycle promotional strategy... ...promotional review processes within a growing organization...Work at officeApnimed
Cambridge, MA3 days ago- ...worldwide. As Executive Director, Global Regulatory Affairs CMC Early... ...Affairs and CMC functions (process development, analytical, formulation... ...will contribute: Leads and develops a team of regulatory... ...changes, analytical readiness, control strategy evolution...Remote workWorldwide
Takeda
Cambridge, MA3 hours ago $209.35k - $258.6k
..., are you? Job Summary The Director, Regulatory Affairs - Labeling is a highly... ...Leadership Define and lead global labeling strategy (USPI... ...efficient execution of labeling processes, including document... ...control, tracking, and inspection readiness across labeling documentation...Work at officeLocal areaRelocationFlexible hours- ...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....Work at officeLocal area3 days per week
$208.2k - $327.14k
...understand that my employment application process with Takeda will commence and that... .... Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of... ...development through registration and launch readiness for high-impact oncology programs....Minimum wageFull timeTemporary workLocal areaRemote workWorldwideTakeda Pharmaceuticals
Boston, MA4 days ago- Praxis Precision Medicines, Inc. is seeking a TMF Operations Lead to ensure accurate and complete clinical trial documentation. The ideal candidate will have over 5 years of experience in TMF management, a deep understanding of ICH/GCP and FDA requirements, and expertise...Remote job
$140k - $175k
...consulting services associated with operational readiness and operational excellence to FDA-... ...operational performance. The ORPM designs and leads holistic Operational Readiness programs... ...OR campaigns integrating with Quality, Process, and Workforce streams. Apply OE...Temporary workFor contractorsWorldwide$238k - $374k
...my employment application process with Takeda will commence and... ...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug... ...How you will contribute: Leads and develops a team of regulatory... ...compliant, inspection-ready processes and documentation...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- ...applications. The candidate's primary role will be to serve as a Lead Cadbidm Coordinator on various large Northeast water and... ...applicant is expected to have advanced Revit modeling skills with process mechanical design experience on water and/or wastewater projects...Full time
Hazen and Sawyer
Boston, MA2 days ago - ...offerings via acquisitions and the launch of new businesses. We are looking for a strong and passionate candidate who will lead process improvement initiatives, the pursuit of NRTL recognition and oversee the continuous improvement of our Quality Management System...Worldwide
NFPA Global Solutions Inc.
Quincy, MA22 days ago $120k - $217.5k
State Street is seeking an IT Asset Management Process Lead in Quincy, MA to govern enterprise ITAM processes across the full asset lifecycle. This role focuses on ensuring consistent and compliant management of IT assets while driving standardization and operational discipline...- ...years of experience in the pharmaceutical industry. The role involves developing user requirement specifications, analyzing clinical processes, and ensuring compliance with industry standards. The ideal candidate will have a bachelor's or master's degree in a related field...
- BNY Mellon is hiring a Senior Specialist in Boston, MA, for their client processing team. This role includes responsibilities like complex analytics, managing client issues, and participating in product development. Candidates should possess a Bachelor's degree and have...
$120k - $217.5k
STATE STREET CORPORATION is seeking an IT Asset Management Process Lead in Quincy, MA, to govern enterprise-wide ITAM processes. This role involves driving standardization and operational efficiency across IT platforms. The ideal candidate will have over 10 years of relevant...- Compass Group USA is seeking a Process Improvement Manager for a premier R&D client in Cambridge, Massachusetts. This position is responsible for leading process governance in various service lines, including Hard Services and Food Services. The role requires a Bachelor...
$75k - $80k
RXO, Inc. is seeking a Manager of Operations Support in New Hampshire. The role focuses on ensuring quality management processes, overseeing training, and driving continuous improvement initiatives across the facility. Qualified candidates should have 5 years of relevant...- Vertex Pharmaceuticals in Boston is seeking a Principal Analyst for CGT Process Automation & AI. The role involves leading process improvements and AI projects, ensuring smooth workflows, and improving documentation practices within the organization. Ideal candidates will...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to TMF Director - Regulatory Readiness & Process Lead. Be the first to apply!
Related searches
- quality regulatory manager Boston, MA
- operations compliance manager Boston, MA
- regulatory affairs director Boston, MA
- regulatory manager Boston, MA
- head compliance Boston, MA
- director global regulatory affairs Boston, MA
- compliance manager Boston, MA
- manager regulatory affairs Boston, MA
- compliance director Boston, MA
- regulatory affairs manager medical devices Boston, MA