Senior Regulatory Strategist First-in-Class Biologics
Paternabio
Paterna Biosciences is seeking a Senior Regulatory Strategist to lead company-side regulatory strategy for an in vitro gametogenesis program. You will own IND/BLA planning, coordinate FDA interactions, and translate biology and data into positions the agency will accept. The role requires a 5+ year track record in biologics or cell therapy regulatory affairs on the sponsor side, plus experience drafting submissions and challenging requirements with scientific justification. #J-18808-Ljbffr Paternabio
- We’re Hiring Regulatory Strategist, Creative and Industry-Tested Location: U.S.-based Employment... ...to fit the right candidate Level: Senior Leadership Who We Are: Paterna Biosciences... ...in vitro spermatogenesis, or IVS: a first-in-class biologic that grows functional sperm from his...Regulatory
- ...developing a portfolio of first- and best-in-class medicines targeting KCC2, a... ...Axonis Therapeutics with a new Senior/Principal Scientist, DMPK... ...intersection of Chemistry, Biology, and Toxicology. Axonis is... ...cascade Author DMPK sections of regulatory documents and respond to...SeniorRegulatory
- NBH Bank in Dallas seeks a Senior Special Assets Officer to develop workout plans for loan clients, coordinating with borrowers, counsel... .../Real Estate lending, with a focus on risk mitigation, regulatory compliance, and cross-functional collaboration #J-18808-Ljbffr...SeniorRegulatory
- Orthogonal is a development and consulting firm that focuses on SaMD and connected medical devices. We seek a Senior Quality and Regulatory Consultant to translate risk and business goals into a right-sized plan and work across a portfolio of engagements rather than being...SeniorRegulatoryRemote job
- ...Medicine Research and Development (VMRD), Swine Biologicals group in Kalamazoo, MI is seeking a Manager or Senior Manager, Swine Clinician, to further efforts in... ...compliance with US CVB and/or EU EMA and/or other global regulatory requirements. The individual will have...SeniorRegulatoryFull time
$155.8k - $233.7k
...organization where we focus on People First, have fun at work and make a... ...-profile initiatives. As a senior individual contributor, this... ...based on project objectives, regulatory and permitting considerations... ...with the Communications Strategist to support information flow,...SeniorRegulatoryTemporary workWork experience placementFlexible hoursShift work- ...commonly prescribed drug class. More than half of... ...02 (SEMDEXA™), is the first non-opioid novel injectable... ...and Responsibilities: Senior Director/Director, CMC... ...and Controls, Regulatory CMC, and Quality Assurance... ...for small molecule or biological injectable products’...SeniorRegulatoryFull timeContract workWorldwide
$200k - $400k
...Columbia, and Cornell with world-class technical staff and operators from... ...Ventures. The Role As Senior Legal Counsel, you will be Traversal's first legal hire, building the legal function... ...(SOC 2, GDPR/CCPA) and emerging regulatory considerations relevant to an AI...SeniorRegulatoryFull timeContract workWork at officeFlexible hours- Voronoi, Inc. seeks a Senior Clinical Scientist to join its Clinical Development team... ...with Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Science,... ...and contribution to regulatory submissions to advance first-in-class #J-18808-Ljbffr VoronoiSeniorRegulatory
$153k - $210k
...Senior Counsel, Commercial page is loaded## Senior Counsel, Commercialremote... ...in navigating structural and regulatory considerations, such as: multi... ....**Cityblock Health is the first tech-driven provider for... ...members. Equipped with world-class, custom care delivery technology...SeniorRegulatoryContract workTemporary workWork experience placementLocal areaWork from home- ...support the Board of Directors and Senior Management to fulfil their statutory and regulatory obligations, by helping to ensure... ...and strengthening the first line of defense culture in day-to... ...wide commitment to ESG and best-in-class technology including a global data...SeniorRegulatoryLocal areaWorldwide
$135k - $155k
...underwriting expertise for homogeneous, niche classes of business. We enjoy the strength... ...nonprofit D&O and EPLI claims from first notice through resolution. Evaluate liability... ...comply with internal guidelines, regulatory requirements, and best practices. Maintain...SeniorRegulatoryFull timeWork at office- Senior Regulatory Reporting Analyst page is loaded## Senior Regulatory Reporting Analystlocations:... ...Cornelius Vander Starr established his first insurance company in Shanghai, China in... ...environment for all employees. We offer first class training and development opportunities...SeniorRegulatoryWork at officeShift work
- # Senior ArchitectAnn Arbor, MIFull-Time# Senior ArchitectAnn Arbor... ...position and attach it as the first page of your resume. The cover... ...recommendations to assure compliance with regulatory agencies and University goals.... ...helps to advance this world-class institution. It's adding a...SeniorRegulatoryImmediate startRemote workFlexible hours
- # Senior Civil EngineerAnn Arbor, MIFull-Time# Senior Civil EngineerAnn... ...position and attach it as the first page of your resume. The cover... ...to assure compliance with regulatory agencies and University goals.... ...here helps to advance this world-class institution. It's adding a...SeniorRegulatoryImmediate startRemote workFlexible hours
$150k - $200k
...-made, and built for the real world. Our first pilot plant in Orangeville, Utah will demonstrate... ...'s pragmatic controls to a future world-class Quality Management System, and begin... ...with judgment, distinguishing between regulatory intent and historical habit. Serve as...SeniorRegulatoryPermanent employmentLocal area$165.07k - $204.23k
...clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective... ...of diverse KRAS-mutant tumors. The Senior Manager, Drug Safety will play a key role... ...of clinical safety principles, global regulatory requirements, safety surveillance, and...SeniorRegulatoryWork at officeLocal area- ## Senior Trade Compliance SpecialistApply: Greensboro, NC: Full time... ...sourcing model and best-in-class supply chain to drive brand growth... ...-term trade strategy, driving regulatory compliance, operational... ...Programs (such as FTZ, Drawback, First Sale, and Free Trade Agreements...SeniorRegulatoryFull timeWork experience placementWork at officeFlexible hoursShift work
$210k - $215k
...disciplined investments, and world-class service. We will do this by... ...we do: Clients Come First - Always | Execution Supersedes... ..., subcontracting, assignment, regulatory access, resilience and termination... ...including the ability to engage senior business partners, influence...SeniorRegulatoryContract workFlexible hours$170k - $220k
## Senior Research AnalystApplylocations: New York, NY: Chicago, IL... ...and up to date on industry and regulatory developments.* Business... ...quantitative and multi-asset class, private equity and hedge funds... ...Pensions & Investments* as the first or second "Best Place to Work...SeniorRegulatoryLocal areaWorldwideShift work- ...EDIT-401 is a potential best-in-class, one-time therapy designed to... ...Your Impact: As the Senior Specialist, Quality Systems Management... ..., applicable international regulatory standards, and regulatory... ...simultaneously. Experience supporting biologics, protein, RNA, cell therapy,...SeniorRegulatoryFlexible hours
- Huntress, a remote-first cybersecurity company, seeks a Senior Sales Operations Business Partner to empower GTM leaders with data-driven decisions. You will translate business goals into KPI reviews, forecasts, and actionable insights that improve pipeline health and seller...SeniorRemote job
- ...LC-MS, and cIEF techniques while mentoring team members and coordinating with QA, Regulatory, and Manufacturing to enable product success. The role requires deep knowledge of biologics analytics and strong communication skills, with a track record of delivering impactful...Regulatory
$90k - $130k
...of the most advanced drugs, biologics, and medical devices in development... ...to join our winning team as Senior Clinical Data Managers for... ...for out of scope tasks; first line contact for technical or... ...support to client audits and regulatory inspections. Follow up on audit...SeniorRegulatoryContract workTemporary workWork at officeRemote workWork from homeWorldwide- ...Principal Scientist II to lead the Analytical Development team within Biologics. This role focuses on advancing late-stage programs with a... ...and cross-functional leadership across CMC, R&D, and regulatory interactions. You will mentor scientists, drive method development...Regulatory
$80.89k - $94.75k
...Infectious Diseases Division seeks a Senior Research Investigator to join... ..., lab management, and regulatory compliance issues • Other... ....* Experience with molecular biology and sequencing is required. Experience... ..., veteran status or any class protected under applicable...SeniorRegulatoryTraineeshipLocal areaFlexible hoursShift work- ...alternative application process. Senior Director, Accounting Full... ...putting science and patients first. We exist to develop... ...functional partners in clinical, regulatory, and legal. At Uniquity Bio... ...and deliver meaningful, best-in-class products. We are looking for self...SeniorRegulatoryFull timeInterim roleWork at officeLocal areaRemote work
- Senior SEO and GEO strategist (AI search) Lead SEO and generative search programs that move pipeline, not vanity metrics. You will own audits, roadmaps... ...been able to double our CTR and conversions within the first month. We couldn't be happiest. “ “This is an incredible...SeniorLocal area
- Docker, Inc. is seeking a Senior Principal Software Engineer to shape the technical landscape and guide a scalable, secure platform. You... ..., and ensuring high performance as Docker scales. This remote-first role opens opportunities to influence a global engineering culture...SeniorRemote job
- ...the heart of everything we do. From our legendary people-first culture to the hundreds of Fingerpainters who define us,... .... Objectives of This Role: We’re looking for a senior engagement / digital strategist who blends left- and right-brain thinking—comfortable mapping...Senior
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