Regulatory Operations Lead, Inflammatory Disease Specialist
1 week ago
Job Overview: We are seeking a highly experienced Regulatory Operations Lead to join our team at Spyre Therapeutics. As a key member of our regulatory operations function, you will play a vital role in ensuring the timely and compliant submission of regulatory documents worldwide.
About the Role: The Senior Manager, Regulatory Operations will be responsible for overseeing all aspects of regulatory submissions, including planning, project management, vendor oversight, document management, and system implementation. This is an excellent opportunity to join a dynamic and fast-paced environment where you can contribute to the development of life-changing products for patients.
Key Responsibilities:
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Waltham, Massachusetts, United States Lifelancer Full timeCompany Overview">Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches.">Job Summary">We are seeking an experienced Regulatory Operations Manager to join...
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Senior Clinical Trial Operations Specialist
2 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeOverviewSpyre Therapeutics, a clinical-stage biotechnology company focused on developing innovative inflammatory bowel disease (IBD) products, is seeking an experienced Senior Clinical Trial Operations Specialist to join its team. The successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to shaping the...
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Senior Regulatory Affairs Specialist
17 hours ago
Waltham, Massachusetts, United States Lifelancer Full timeAbout Apogee TherapeuticsApogee Therapeutics is a biotechnology company focused on developing innovative treatments for atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications.We are committed to building an exceptional company culture grounded in our C.O.R.E. values: Caring, Original, Resilient, and...
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Waltham, Massachusetts, United States Lifelancer Full timeUnlock a Rewarding Career in Clinical TrialsIn this pivotal role as Senior Clinical Trial Associate, you will play a crucial part in shaping the future of inflammatory bowel disease (IBD) treatments. Join our dynamic team at Spyre Therapeutics, a clinical-stage biotechnology company dedicated to creating innovative therapies for patients.Competitive Salary...
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Regulatory Affairs Strategist
3 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeJob Title: Regulatory Affairs StrategistWe are seeking a skilled Regulatory Affairs Strategist to join our team at Apogee Therapeutics. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's regulatory strategies and ensuring compliance with US and international regulations.About Apogee TherapeuticsApogee...
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Biotech Regulatory Affairs Manager
3 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeUnlock Your Career in Biotech Regulatory AffairsA dynamic opportunity awaits at Apogee Therapeutics, a well-funded biotechnology company pioneering innovative treatments for inflammatory and immunology indications.The ideal candidate will possess a strong background in regulatory affairs, with a minimum of 4 years of experience working in drug development in...
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Senior Scientist, Immunology Expert
3 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeAbout the Role:We are seeking an exceptional Senior Scientist, Immunology to join our team at Upstream Bio in Waltham, MA.The ideal candidate will have a strong background in immunology and inflammatory diseases, with experience in biologics drug discovery. They will be responsible for providing biology and translational expertise for clinical development of...
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Waltham, Massachusetts, United States Lifelancer Full timeJob Title: Clinical Trial Associate Position, Clinical Operations SpecialistJob Location: United StatesJob Type: Full-timeJob Seniority Level: Entry levelAbout Spyre Therapeutics:Spyre Therapeutics is a clinical-stage biotechnology company dedicated to creating innovative inflammatory bowel disease (IBD) products. We combine advanced antibody engineering,...
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Medical Director
17 hours ago
Waltham, Massachusetts, United States Lifelancer Full timeWe are seeking a seasoned Medical Director to lead our clinical development efforts in Immunology and Inflammation. This is an exceptional opportunity to shape the future of innovative therapies targeting immunological and inflammatory indications.The ideal candidate will possess a strong background in clinical development, with a proven track record in...
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Senior Rare Disease Specialist
2 weeks ago
Waltham, Massachusetts, United States Sobi Full timeJob OverviewWe are seeking a highly skilled Senior Rare Disease Specialist to join our team at Sobi. This is an exciting opportunity for someone who is passionate about working with patients and partners to bring innovative solutions to those affected by rare diseases.
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Senior Regulatory Affairs Operations Manager
1 week ago
Waltham, Massachusetts, United States Lifelancer Full timeUnlock your potential in a dynamic biopharmaceutical company.Syndax Pharmaceuticals is seeking a Senior Regulatory Affairs Operations Manager to support the quality and timely regulatory submissions for all company products.This role involves implementing regulatory systems, establishing processes, and overseeing global submissions, working closely with...
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Regulatory Affairs Specialist
3 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeAre you a skilled Regulatory Affairs Specialist looking to make a significant impact in the Life Sciences industry?Lifelancer is seeking a highly experienced professional to join our team as a Senior Regulatory Affairs Specialist. This role offers the opportunity to work on high-profile projects, collaborate with cross-functional teams, and contribute to the...
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Waltham, Massachusetts, United States Sobi Full timeSobi, a specialized biopharmaceutical company dedicated to rare diseases, seeks a Director of Health Economic and Outcomes Research (HEOR) and Real-World Evidence (RWE) to join our growing Medical Affairs team in North America. This remote position requires residing within the US, preferably in the central or eastern time zone.Job Summary:The successful...
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Waltham, Massachusetts, United States Sobi Full timeAbout the RoleAt Sobi, we are dedicated to developing and delivering innovative therapies to improve the lives of people who live with rare diseases. We are seeking a highly skilled Lead Operations and Analytics Manager to join our Contracts & Pricing team.Key ResponsibilitiesAnalyze customer submitted data, verify contract pricing terms, contract adherence,...
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Regulatory Affairs Operations Manager
3 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeAbout the RoleAt Lifelancer, we are looking for a highly skilled Regulatory Affairs Operations Manager to support our clients in the biotechnology and pharmaceutical industry. As a key member of our team, you will be responsible for coordinating and preparing regulatory submissions to health authorities, including FDA, EMA, and other national...
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Clinical Operations Specialist, Life Sciences
3 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeCompany OverviewSpyre Therapeutics is a dynamic clinical-stage biotechnology company that aims to revolutionize the field of inflammatory bowel disease (IBD) treatments.The company's innovative approach combines best-in-class antibody engineering, rational therapeutic combinations, and precision medicine techniques.Spyre Therapeutics is committed to...
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Waltham, Massachusetts, United States Lifelancer Full timeCompany Overview:Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches.The company's pipeline includes investigational extended half-life antibodies...
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Clinical Operations Manager
3 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeAbout the RoleWe are seeking a seasoned Clinical Operations Manager to lead our verekitug clinical development program.Job Summary:This is a senior leadership role that will oversee the planning, execution, and delivery of large-scale global clinical trials for the treatment of severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic...
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Waltham, Massachusetts, United States Lifelancer Full timeSpyre Therapeutics, a clinical-stage biotechnology company, seeks a Senior Director of Immunology and Inflammation Clinical Development to lead the clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications.This role requires strong leadership and medical expertise to provide strategic guidance...
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Senior Immunology Research Director
3 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeAbout the Opportunity:We are seeking a highly skilled Senior Scientist, Immunology to join our team at Upstream Bio. This is an excellent opportunity for a scientific professional with expertise in immunology and inflammation to contribute to the development of verekitug, a novel antagonist targeting the receptor for Thymic Stromal Lymphopoietin (TSLP).Key...