Regulatory Affairs Lead: Early-Phase Biologics (Remote)
Tonix Pharmaceuticals
- Remote job
Tonix is seeking a full-time Associate Director, Regulatory Affairs to lead regulatory strategies for novel biologics or drugs in early development, from pre-IND through clinical development and marketing application, working with cross-functional teams and regulatory authorities. This role reports to the Co-Head of Regulatory Affairs, Management and Execution, and can be based in a Tonix office or remotely. #J-18808-Ljbffr Tonix Pharmaceuticals
- ...seeks a Principal Statistician for Early Phase, fully home based. Lead statistical activities across trials... ...biostatisticians, and contribute to SAPs and regulatory submissions. With a PhD/MS in... ...analyses from protocol through CSR. Remote work across Europe, shaping early...Remote jobWork from home
- ...Fast. Quotient Sciences is a leading drug development and... ...professional with deep expertise in early-phase clinical development and a... ..., with a particular focus on biologics. This is an opportunity to partner... ...to work independently in a remote environment while...Remote workFull timeContract workLocal areaWork from homeWorldwide
- A leading global CRO is seeking a Principal Biostatistician to provide scientific and statistical leadership in early-phase studies focused on PK/PD. Responsibilities include leading study design... ...experience. The role is fully remote and offers the chance to impact groundbreaking...Remote work
- ...Director, Global Regulatory Strategy-... ...Global Regulatory Lead responsibilities... ...programs.Work with Early Development... ...key meetings. Remote-first candidates... ...Bachelor's degree in biology, Life Sciences,... ...in Regulatory Affairs within the... ...spanning multiple phases of clinical...Remote workFull timeLocal area
$227.42k - $275.58k
...expertise and resources of a leading innovator in oncology.... ...leader to lead our biology organization. This... ...Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology... ...IND filings and early clinical development.Knowledge... ...centers. Employees in remote-by-design or lab-based...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startFlexible hours$270k - $360k
...development in cardiometabolic diseases. Responsibilities include leading clinical strategy, ensuring quality documentation, and engaging... ...in biotech/pharma. This position offers the flexibility of remote, hybrid, or on-site work, with a competitive salary range of $2...Remote work$130k - $200k
A leading biotechnology company is seeking a Director of Regulatory Affairs for Infectious Diseases. This position is responsible for overseeing global regulatory strategies... ...experience. The role offers the flexibility of remote work and requires interaction with regulatory...Remote job- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote job
$238k - $374k
...group of experienced biologic drug hunters with the... ...and the resources of a leading pharmaceutical company... ...the medicine vision and early asset strategy... ...business acumen including regulatory (BLA/MAA pathway) and... ...by Takeda’s Hybrid and Remote Work policy.Takeda Compensation...Remote workMinimum wageTemporary workLocal area- ...seeking a Policy Advisor to serve as the expert on early childhood education policy, licensing, accreditation, and regulatory compliance. You will monitor legislative... ...standards, and accreditation efforts. You will lead licensing guidance, pre-opening strategy, inspections...Remote job
- ...company is seeking a Clinical Trial Manager (CTM) to lead early-phase oncology studies remotely. The ideal candidate will have at least 5 years of clinical... ...Lead. This role involves overseeing CROs, ensuring regulatory compliance, and supporting trials from start-up to...Remote job
- Description Principal Statistician - Early Phase - Fully home based (remote anywhere in Europe) Sponsor Dedicated Syneos Health® is a leading fully-integrated life sciences services... ...submissions, integrated analyses), and attend regulatory agency meetings or responds to...Remote jobContract workWork from home
- Arbor Biotechnologies seeks a Senior Clinical Trial Manager in Cambridge, MA to lead early-phase studies and report to the Senior Director of Clinical Operations. The role will manage trials from startup to close-out, overseeing study sites, master files, CROs, and study...
$238k - $374k
...DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...for small molecule and biologic products through Phase 2 development. You will... ...China).ACCOUNTABILITIES Leads and develops a team of... ...Takeda’s Hybrid and Remote Work policyTakeda Compensation...Remote workMinimum wageTemporary workLocal area$170.45k - $243.5k
...Global Statistical Lead (GSTATL) for... ..., medical affairs statistics, real... ...a key role in regulatory and payer strategy... ...functions (e.g., e.g., phase 1b/2 signal-... ..., engineered biologics, engineered... ...leaders and navigate early-stage biotech... ..., IL. Remote work from anywhere...Remote workWork at officeWork from homeWorldwide$132k - $172k
...vision of becoming a leading biopharmaceutical... ...Manager, CMC Regulatory Affairs is responsible for... ...activities for biologic products, with a... ...stage development, Phase 3 programs, and rare... ...programs from early development through... ...to be 100% remote.Total Rewards Offerings...Remote workFull timeTemporary workWorldwide$144.06k - $205.8k
...global leadership role in the Regulatory Affairs department for the Chemistry... ...:Acts as a CMC regulatory lead for highly complex projects/... ...RequirementsRequired Qualifications:BS in Biology or equivalent degree10 years... ...based in Westborough, MA. Remote work from anywhere in the US...Remote workWork at officeLocal areaWork from homeWorldwide$212k - $333.19k
...of my knowledge.Job DescriptionSenior Director, AIRx Discovery Biology Lead Takeda Research is constructing the Discovery Automation &... ...position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policyTakeda Compensation and Benefits SummaryWe...Remote workMinimum wageTemporary workLocal area$177k - $278.08k
...therapies, including ADCs, complex biologics and small molecules. Our... ...as a Director, Global Regulatory Lead Oncology where you will be part... ...concepts within regulatory affairs and implications across the... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA...Remote workMinimum wageTemporary workLocal areaWorldwide- ...Job Description Please note: Must have early learning experience and be based out of,... ...everything we do. NATURE AND SCOPE: The Lead Evaluator, Early Learning will provide high... ...laws, rules, or regulations. Cognia is an Equal Opportunity Employer. #LI-remote...Remote workPart timeWork experience placementWork at officeLocal area
- ..., is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for... ...in CMC regulatory requirements for biologics and gene therapies. The ideal candidate... ...collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workFlexible hours
- Cambium Learning Group seeks an Early Childhood Literacy Assessment Specialist to develop and quality assure English-language literacy content for grades K-2. You will collaborate with content developers, psychometricians, and program teams to ensure linguistic accuracy...Remote job
- ...Research Lab Specialist Lead to serve as the... ...pairs deep RNA/splicing biology with production-grade genomics... ...work.Manage all phases of large, complex research... ...eligible for hybrid or mobile/remote work mode are at the... ...process may begin as early as the eighth day after...Remote work
$144.06k - $205.8k
...This position plays a key role in the regulatory affairs department. Responsible for developing... ...Scientific knowledge in chemistry, general biological/physical science and ability to apply... ...position is based in Northbrook, IL. Remote work from anywhere in the US is...Remote workContract workWork at officeWork from homeWorldwide$109k - $174.8k
...merit. Job Function: Regulatory Affairs Group Job Sub Function:... ..., United States of America, Remote (US), Santa Clara, California... ...innovation at the intersection of biology and technology, we’re... ...Regulatory Affairs Program Lead to support our Instrumentation...Remote workFull timeLocal areaImmediate start$202.13k - $336.88k
...DPosition Summary:As the Senior Director, Early Phase CMC Medicine Research Leader you will... ...recruiting of CMC project matrix leaders who lead programs in support of Early Development... ..., supply chain, quality and CMC regulatory strategy through leadership of the CMC/Supply...Full timeLocal area$200.39k - $250.33k
Ionis Pharmaceuticals, Inc. is seeking a Director of Computational Biology in Boston to lead target identification and multi-omics research. This role requires a PhD and 8+ years of experience in the field, with a proven track record in multi-omics approaches. Responsibilities...Remote job$110k - $145k
...a seamless approach to every phase of a project - from planning and... ...systems and foundation/early construction management experience... ...theindividualwillnotbepermittedtoperformsafety-sensitivefunctions. Office/Remote/Field Work:... ...by the Secretary of Veterans Affairs; or a person who was...Remote workHourly payFull timeContract workFor contractorsFor subcontractorWork at officeWork visaFlexible hours3 days per week$265k - $290k
...President, Global Compliance Lead Reporting Location:... ...90,000 Workplace Type: Remote TEAM : Global Category... ...and governing all regulatory, environmental, safety,... ...partnering with government affairs professionals, external... ...positioning statements Provide early visibility to...Remote workLive inWork at officeShift work- Armiusa seeks a Senior Regulatory Affairs Consultant to develop regulatory strategies and ensure compliance for complex biologics and devices. Candidates should have extensive experience in regulatory affairs and a strong educational background in life sciences or engineering...
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