Director, Global CMC Regulatory Affairs
Enigma Search
Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies, shaping strategies for accelerated development and successful product registrations. The role partners with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory readiness, and oversee changes across regions from development through commercialization. #J-18808-Ljbffr Enigma Search
$187.8k - $208.6k
...seeks a Senior Manager or Associate Director to lead CMC regulatory strategy for small molecule programs... ...Responsibilities Develop and execute global CMC regulatory strategies for... ...field ~ Minimum 6+ years regulatory affairs experience with substantial CMC focus...Suggested$209k - $260k
...drug innovators and financed by top-tier global life sciences investors. The company... ...to SVP Technical Operations, the Director Technical (CMC) Project Management will provide technical... ...substance, drug product, analytical, quality, regulatory, and supply chain activities.Ensure...SuggestedContract work$185k - $205k
...treatment paradigm and provide access to a $15 billion global market opportunity. Our follow-on product candidate, OP-... ...career, and for what’s beyond. About the Role >>> Associate Director, Global Regulatory Affairs, Compliance and Project Management As the Global...SuggestedWork at officeFlexible hours$185k - $250k
...drug innovators and financed by top-tier global life sciences investors. The company... ...geographic location.Position Summary:The Director, Global GCP QA is responsible for governance... ...expert GCP guidance across global regulatory requirements (FDA, EMA, MHRA, NMPA, PMDA...SuggestedContract workRemote work$252.8k
The PositionWe are excited to be hiring a Senior Director of Global Litigation Management, Global Legal Pharma. This role reports directly to the Head of Global Litigation and oversees three operations teams (GLP’s Litigation Resource Center, eDiscovery, and the Information...SuggestedFull timeTemporary workLocal areaRemote workRelocationRelocation package$240k - $280k
...The Senior Director, Biostatistics provides strategic statistical... ...clinical studies that support regulatory submissions and advance innovative... ...Sciences, Regulatory Affairs, Data Management, Statistical... ...Provide statistical leadership for global regulatory interactions,...Work experience placementInterim roleWork at office$180k - $241k
...has secured partnerships with leading global biopharmaceutical companies, generating... ...Primary Function: The Associate Director, Regulatory Affairs supports the development and execution... ...Nonclinical, Biometrics, Medical Writing, CMC, and other functions. Partner with CMC...Full timeRemote workWorldwideRelocation package- ...for generations to come.Regulatory Submission Management (... ...portfolio, to ensure global Regulatory submissions... ...companion across Regulatory Affairs, bridging strategy and... .... As an Associate Director, RSM, you will have a primary... ..., such as Regulatory CMC, as appropriate, via...Full timeFor contractorsLocal areaRelocationFlexible hours
$218.33k - $327.49k
...AstraZeneca’s Therapeutic Area Units. The Global Analytics & Insights mission is to... ..., and competitor analytics. The Senior Director, Global Analytics & Insights, Cell... ...strategically with Global Commercial, R&D, Medical, Regulatory, Market Access, and Operations teams,...Hourly payTemporary work$218.33k - $327.49k
...AstraZeneca seeks a Senior Director to lead global analytics and insights for its Cell Therapy Enterprise. The role involves developing market... ...Partner with Global Commercial, R&D, Medical, and Regulatory teams to provide independent insights for asset and portfolio...$162.5k - $227.5k
...coordinate, and drive cross-functional CMC activities supporting early-... ...Development, Quality, Regulatory, and Supply Chain to ensure successful... ...Development, CMC Regulatory Affairs, Quality, Technical Operations... ...alliances, and remote or global teams is preferredWHO WE ARE AND...Full timeWork at officeRemote workWork visa3 days per week$193.5k - $236.5k
...Associate Director, CMC Project ManagementJoin Maze Therapeutics as our Associate Director, CMC Project Management. In this highly visible... ...internal stakeholders to enable program milestones, support regulatory success, and ultimately help bring potential medicines to...Work at officeShift work$199.75k - $246.75k
...,000 companies, including Bridgestone, New Balance, Nucor, S&P Global, and Sony Music, trust Freshworks’ customer experience (CX) and... ...people — and this role is at the center of that transformation. As Director of Performance Management & Employee Listening, you will lead...Flexible hoursShift work$243.1k - $314.6k
...and help create possible, together.Job DescriptionSenior Director, Global Public Affairs, Inflammation Reporting to the Executive Director of... ...pipeline candidates, clinical studies in specific populations, regulatory filings, and novel educational and access-related...Full timeFor contractorsLocal area$224k - $308k
...defining work. We're all in on this mission. If you are too, let's talk.We are seeking a visionary and operationally rigorous Director, Global Tech Recruiting to define, drive, and own the end-to-end talent acquisition strategy across our global Product & Technology organizations...Work at officeLocal areaWorldwideFlexible hours2 days per week$172k - $215k
...intelligent infrastructure that powers global commerce, seamlessly... ...what comes next.Job Title:Director, Government AffairsCompany:PrologisA... ...Director of Government Affairs develops and executes Prologis... ...market teams on legislative, regulatory, policy, and public affairs risks...Full timeLocal area- ...fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionThe role serves as a key liaison across Global Medical Affairs and external stakeholders, driving project execution, process optimization, governance, and performance measurement while...Full timeContract workFor contractorsWork at officeLocal area
$167.3k - $245.4k
...exceptional product, modern design, and compelling storytelling with the power and scale of one of the world's most iconic brands. As Director, Global Merchandising - Blue Tab, you will set the product vision, shape the consumer and category strategy, bringing together a...Full timeSeasonal workWork at officeLocal area3 days per week$281.01k - $363.66k
...developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Senior Director, Global Medical Affairs (GMA) Inflammation Strategy is a key member of the GMA Liver, Inflammation, Emerging Viruses, and Established Products...Full timeFor contractorsWork at officeLocal area$231.5k - $289.4k
...our mission to change the way people see the world.Planet is a global company with employees working remotely world wide and joining... ...behind how Planet finds, attracts, and hires that talent.As Senior Director, Talent Acquisition, you will own Planet's global hiring...Full timeTemporary workWork at officeLocal areaRemote workHome office3 days per week$240k - $338k
...across multiple constituents - partners, creators, consumers, and developers.Position Overview:We are seeking an experienced leader in Global Communications to shape and manage Dolby’s global reputation. This role is responsible for developing and executing a global...Full timeLocal areaWorldwideFlexible hours$161k - $227.5k
...and sustaining projects. Identify new high-potential suppliers globally. Cultivate productive relationships with supply chain partners,... ...compensation) under laws administered by the Secretary of Veterans Affairs, or was discharged or released from active duty because of a...Full timeContract workFor contractorsFor subcontractorWork at officeLocal areaRelocation package- ...rise in costs, and supply chain disruptions. What has been a "sleepy" industry for decades is now at the epicenter of sustaining the global economy.As Staff GSM, Contract Manufacturing, you'll own one of the most strategically consequential parts of Mytra's supply chain:...Contract workWork at office
$139k - $261.15k
The OpportunityWe're looking for a strategic and execution-focused Senior Global Total Rewards Operations & Project Manager to partner with the Total Rewards function! This role bridges planning and implementation, ensuring strong alignment, prioritization, and delivery...Full timeTemporary workLocal areaRemote workWorldwide$120.2k - $223.2k
The PositionCommercial Regulatory Affairs (CORA) is part of the Global Product and Access Legal (GPAL) organization that interprets the needs of worldwide... ...the Global Legal Pharma Department.Associate Program Directors of Commercial Medical Legal Regulatory Review Committees...Full timeWork experience placementLocal areaWorldwideRelocation package$165k - $185k
...Director, Global Partnerships San Francisco, CA With millions of diners, 60,000+ restaurant partners and 25+ years of experience, OpenTable, part of Booking Holdings, Inc., is an industry leader with a passion for helping restaurants thrive. Our world-class technology...Contract workWork at officeLocal areaFlexible hours2 days per week$178.1k - $292.17k
Role SummaryTemporal is hiring a Director, Global Developer Success to lead and scale our deeply technical support organization. This is a high-impact leadership role responsible for turning customer technical response into a repeatable, measurable, and differentiated...$186k - $235k
...and financed by top-tier global life sciences investors... ...Summary:The Associate Director of Medical Writing will... ...the development of key regulatory and clinical documents... ...Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance... ..., Nonclinical, CMC, and Program Management...Contract workRemote work$176k - $206k
...a key strategic role within a matrixed global vaccine organization, responsible for orchestrating... ...and Technology, Quality Control, Regulatory Affairs, Manufacturing, and external partners... ...and assignments.Reports to: Senior Director, Quality Control Location: San Carlos,...$204k - $240k
...purchases, working directly with scientists to turn experimental plans into workable contract terms.Help Advance the Pipeline: Support CMC and Research & Development teams on CRO and CDMO agreements.Contract for Compute: Negotiate the cloud, compute, and infrastructure...Contract workFor contractorsHome officeFlexible hours3 days per week
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