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📑 Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - will work partly in office and partly remote. Looking for a Regulatory Affairs Specialist with at least 2 years of regulatory experience along with submissions. Will work on IND submissions (publishing and structure of the IND, not ...

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📑 If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Associate Director, Regulatory Affairs CMC Full Time Mgr & Dir - R&D/Ops Malvern, PA, US 10 days ago Requisition ID: 1072 The Associate Director, Regulatory Affairs CMC will le ...

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📑 Senior Director, Regulatory Affairs*Bay Area- Hybrid*Meet has partnered with a fantastic Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. You will be coming in to lead their Oncology portfolio and you'll be reporting into the VP of Regula ...

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📑 Associate Director/Director, Regulatory Affairs (Oncology)Remote - East Coast CandidatesMeet has partnered with a very well-established pharma with roughly 20 approved products and a robust development pipeline. They are looking for an Associate Director or Director of Regulatory Strategy to join their team. This role will be reporting into the VP ...

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📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing ap ...

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📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing ap ...

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📑 We are partnered exclusively with an exciting biotech company who are looking to bring on their first hire within their regulatory affairs department. Role can be at Director or Senior Director level.The team are looking for individuals with the following experience:Authoring and submitting an IND (the company is a year away from submitting its fir ...

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📑 Clinical Development Leader (Medical Director to Senior Director level)San Francisco (remote/hybrid) **MUST reside on the West Coast or willing to relocate**Full-timeSciPro is working with one of the most exciting names in Oncology. This position holds high visability and will report directly to the CMO.My client is on the verge of going public due ...

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📑 I am partnered with a Small growing biotechnology company in the San Francisco area that is looking for a Pharmacokinetics expert to join their team! In this position you would be given the opportunity to be the first Pharmacokinetics expert and begin to build out the team along the way. My client is looking for an individual that can come in and h ...

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📑 Clinical Development Leader (Medical Director to Senior Director level)San Francisco (remote/hybrid) **MUST reside on the West Coast or willing to relocate**Full-timeSciPro is working with one of the most exciting names in Oncology. This position holds high visability and will report directly to the CMO.My client is on the verge of going public due ...

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📑 Director, Clinical Development - Specialty Medicine page is loaded Director, Clinical Development - Specialty Medicine Apply remote type Hybrid Work Arrangement locations Basking Ridge, NJ time type Full time posted on Posted 3 Days Ago job requisition id R2939 Join a Legacy of Innovation ...

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📑 Associate Director, Global Regulatory Affairs - Early-Development ** Rare Diseases ** PIP's and ODD's** Boston, MAWe have a new RA Associate Director position with a Greater Boston-based Rare Disease Biotech, which is well-funded with a broad portfolio of TA's and indications across a variety of modalities who are led by a talented and highly regar ...

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📑 GeneCoda has been retained to identify and evaluate candidates for a Chief Medical Officer (CMO) to onboard in late Q2 or early Q3 of 2023 and to be located in the Research Triangle Park, NC. Some relocation assistance can be provided for candidates not already located in the region. Learn why the RTP, NC area as a global life sciences leader m ...

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📑 Director / Senior Director, Nonclinical SafetyNimbus has an outstanding opportunity for an exceptional Director / Senior Director of Nonclinical Safety (Toxicology) to join our rapidly growing team. This role will lead the safety strategy, from discovery through both nonclinical and clinical stages, and direct all phases of early investigative toxi ...

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📑 Requisition Number2229806 Description & Requirements Location: Location: This position can be filled in any of our FORVIS office locations or can be a fully remote work opportunity. Ready to Accelerate Your Career? Join our rapidly expanding advisory team! Our Advisory practice brings our f ...

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📑 Reporting to our Senior Director, Drug Product, Process Development, we are seeking an Associate Director to join our team. This position is predominantly a lab-based role and will be responsible for developing scalable processes for LNP delivery of gene-editing RNA cargos. This position will play a critical role in successfully developing manufact ...

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📑 A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is building a pipeline of therapies that target rare and common cardiometa ...

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📑 A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is building a pipeline of therapies that target rare and common cardiometa ...

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📑 A California-based biopharmaceutical company is looking to add an experienced professional to their CMC Quality Control Department as a Writer / Reviewer. In this role, the CMC Quality Control Writer / Reviewer will be responsible for authoring, drafting. reviewing, and approving the Regulatory QC CMC sections of the company's IND/IMPD and BLA/NDA ...

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📑 ** Assoc Dir RA, Boston ** Working on rare diseases, obesity, liver in early and mid-phase compounds for a smaller and stable company with higher visibility from an exclusive leadership teamDo you want to be autonomous in your work and interact closely with the leadership team, to have higher visibility and more opportunities to grow …… then this c ...

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📑 RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Director/AD, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of rare cancer and solid tumours.The candidate will report directly to the Head of RA, ...

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📑 Work at ROCKET PHARMA and help cure rare diseases!Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looki ...

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📑 Work at ROCKET PHARMA and help cure rare diseases!Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looki ...

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📑 Do you want to be part of a growing world-class organization focused on bettering our world? Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!AmplifyBio is a newly established, commercially focused preclinical CRO that was created ...

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📑 3D Systems, Inc. Chief Scientific Officer Houston , Texas Apply Now Position: Chief Scientific Officer (Fractional - Remote) About Us: Systemic Bio is a fast-growing biotech company with a $15M seed investment focused on advancing pharmaceutical drug discovery and development through the application of advanced bioprinting technolog ...

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📑 This is an opportunity to work with an innovative biotechnology company working on the development and manufacturing of small molecules for a diverse portfolio of therapeutic targets. To support the continued growth of the pipeline, we are looking for an experienced Senior/Executive Director of CMC to guide strategy.Responsibilities:Oversee vendors ...

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📑 This is an opportunity to work with an innovative biotechnology company working on the development and manufacturing of small molecules for a diverse portfolio of therapeutic targets. To support the continued growth of the pipeline, we are looking for an experienced Senior/Executive Director of CMC to guide strategy.Responsibilities:Oversee vendors ...

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📑 Director, Clinical Development - Immunology*Remote for East Coast Candidates*Meet has partnered with a well-established pharma based on the East Coast! They are looking for a Director of Clinical Development to join their immunology department. This position will be reporting into a Senior MD and will be supporting multiple global clinical programs ...

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📑 Director, Clinical Development - Immunology*Remote for East Coast Candidates*Meet has partnered with a well-established pharma based on the East Coast! They are looking for a Director of Clinical Development to join their immunology department. This position will be reporting into a Senior MD and will be supporting multiple global clinical programs ...

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📑 Associate Director, Regulatory AffairsThis position will serve as the company US Agent and a contact point between the FDA and company sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Senior Regulatory Associates ...

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📑 Associate Director, Regulatory AffairsThis position will serve as the company US Agent and a contact point between the FDA and company sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guidance to internal constituents. It will lead a team of Regulatory Associates and Senior Regulatory Associates ...

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📑 Senior Medical Director, Drug Safety and Pharmacovigilance Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that yo ...

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📑 About Firefly Bio:Firefly specializes in Degrader Antibody Conjugates (DACs) which combine the unique strengths of ADCs with selective protein degraders. Our state-of-the-art platform results in highly specific delivery of degraders to target tissue. Our mission is to realize the full potential of ADCs by unlocking new classes of payloads. Our comp ...

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📑 About Firefly Bio:Firefly specializes in Degrader Antibody Conjugates (DACs) which combine the unique strengths of ADCs with selective protein degraders. Our state-of-the-art platform results in highly specific delivery of degraders to target tissue. Our mission is to realize the full potential of ADCs by unlocking new classes of payloads. Our comp ...

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📑 DescriptionDescriptionWhen you join LEVERAGE, you’ll set your career on track for outstanding achievement with a national, full-service integrator. We are a technology-based business solution provider that span the enterprise, serving the diverse business needs of large public and private organizations across America. We offer a challenging and dyn ...

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📑 Our innovative Oncology ADC Pre-IPO biotech client is seeking a Medical Director / Senior Medical Director with strong Oncology Clinical Development experience to cover development programs spanning phases I, II, III.Responsibilities:Providing clinical leadership; from early-stage clinical trial design for novel cancer drugs through to CoP stageWor ...

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📑 RBW is partnering with an innovative clinical-stage, Biotech in their search for a newly created position - (Sr.) Director, R&D Quality Assurance. Our client is focused on discovering and developing medicines for the treatment of Crohn's and other inflammatory diseases.The candidate will report directly to the Head of QA, and this role will be resp ...

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📑 RBW is partnering with an innovative clinical-stage, Biotech in their search for a newly created position - (Sr.) Director, R&D Quality Assurance. Our client is focused on discovering and developing medicines for the treatment of Crohn's and other inflammatory diseases.The candidate will report directly to the Head of QA, and this role will be resp ...

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📑 A clinical-stage biotech focused on Rare Diseases. This company utilizes antibodies to harness the bodies immune system to fight off disease.The RoleThis person ill serve as the GRL for the company's early stage proprietary pipeline as well as supporting partnered programs with large pharma , reporting into the SVP of Regulatory Affairs.Main Respon ...

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📑 About Firefly Biologics:Firefly Biologics is a Bay Area venture-backed company currently operating in stealth mode. Our mission is to unlock the full potential of bioconjugates and develop medicines with long-lasting benefits for patients. We are establishing an expert team to build state-of-the-art platform capabilities for the invention and devel ...

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📑 Career CategoryScientificJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researchin ...

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📑 ** IMMEDIATE HIRE & PERMANENT EMPLOYMENT - Warehouse Associate - 3rd Shift - $17.50/hour****Job Category****:** Ind Contributor-NonExempt **Requisition Number****:** WAREH012928 Showing 1 location **Job Details****Description****Warehouse Associate 2 - 2nd** **shift, 530pm-2am****$16.25 plus shift differential $1.25****IMMEDI ...

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📑 ** IMMEDIATE HIRE & PERMANENT EMPLOYMENT - Warehouse Associate - 2nd Shift - $17.50/hour****Job Category****:** Ind Contributor-NonExempt **Requisition Number****:** WAREH012928 Showing 1 location **Job Details****Description****Warehouse Associate 2 - 2nd** **shift, 530pm-2am****$16.25 plus shift differential $1.25****IMMEDI ...

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📑 An exciting biotechnology company are growing out their clinical trial function and consequently, looking for a Director, Clinical Operations to join the team based out of Massachusetts.About the CompanyAt the forefront of groundbreaking clinical trials, this company is spearheading scientific discoveries in the fields of oncology, cardiology, and ...

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📑 Title: Director/Senior Director of Regulatory Salary: $200,000 to $270,000Summary: An Oncology based biotech client of ours is looking to fill their Director/Senior Director role based out of their facility in the San Francisco Bay Area. They are looking for very committed and passionate candidates who can collaborate with their colleagues to help ...

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📑 About Firefly Biologics:Firefly Biologics is a Bay Area venture-backed company currently operating in stealth mode. Our mission is to unlock the full potential of bioconjugates and develop medicines with long-lasting benefits for patients. We are establishing an expert team to build state-of-the-art platform capabilities for the invention and devel ...

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📑 Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and se ...

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📑 CMC Process Development Consultant 2023623Location: Greater Boston, MA (Hybrid)Therapeutic Area: OncologyJob Overview: In this role, the main focus will be on managing CMC processes, coordinating with vendors, overseeing drug substance development, and reviewing various documentation.Primary Job Responsibilities: Manage CDMOs and vendors, ensu ...

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📑 Our client is a specialty pharmaceutical company committed to helping everyone they serve live their best life through the delivery of quality, life-enhancing therapies. Their decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, they boldly transform insights into tr ...

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📑 Our clinical-stage biopharmaceutical client is seeking a Medical Director / Senior Medical Director with strong Oncology Clinical Development experience to cover development programs spanning phases I,II,III.Responsibilities:clinical leadership; from early-stage clinical trial design for novel cancer drugs through to CoP stageclosely and liaise wit ...

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