Regulatory Affairs Manager
3 weeks ago
Responsibilities: Manages most aspects of company regulatory interface with domestic and international health authorities. Manages the development and deployment of the regulatory program that ensures aggressive product approval. Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration. Manages the submissions of clinical study submissions. Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance. Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects. Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations. Provides guidance with localization and labeling requirements. Manages regulatory reporting. Requirements: Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline. 5 + years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries. Strong analytical and problem-solving skills. Strong written and verbal communication skills, including the ability to interact effectively and to influence.
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Menlo Park, United States Meet Full timeSenior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...
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Menlo Park, United States Meet Full timeSenior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...
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menlo, United States Meet Full timeSenior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...
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Regulatory Affairs Senior Associate/Manager
5 days ago
Florham Park, New Jersey, United States Exeltis Full timeJob OverviewPosition Summary:As a key member of the Regulatory Affairs team, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both developmental initiatives and existing FDA-approved products. Your expertise will be crucial in preparing high-quality ANDA submissions, including amendments, supplements, and Annual...
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Regulatory Affairs Senior Associate/Manager
4 days ago
Florham Park, New Jersey, United States Exeltis Full timeJob OverviewPosition Title: Senior Associate/Manager, Regulatory AffairsSalary: CompetitiveRole Summary:In this position, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both development initiatives and currently approved products. Your primary responsibility will be to prepare high-quality ANDA submissions,...
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Senior Associate/Manager, Regulatory Affairs
4 weeks ago
Florham Park, United States Exeltis Full timeJob DescriptionJob DescriptionSalary: Role Overview In this role, you will be a Regulatory lead for submission planning and submission strategy for development projects and existing (FDA Approved) products. You will be expected to prepare high quality ANDA submissions (including amendments, supplements and Annual Reports) with the support and oversight of...
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Regulatory Affairs Senior Associate/Manager
4 days ago
Florham Park, New Jersey, United States Exeltis Full timeJob OverviewSalary: CompetitiveRole Summary:In this position, you will take on the role of Regulatory lead, focusing on submission planning and strategy for both development initiatives and currently marketed products. Your responsibilities will include the preparation of high-quality ANDA submissions, including amendments, supplements, and Annual Reports,...
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CMC Regulatory Affairs Manager
1 week ago
Florham Park, United States Clinical Resource Network (CRN) Full timeOur client is looking to fill the role of CMC Regulatory Affairs. This position will be hybrid and based out of the Florham Park office.Salary: $140-150kResponsibilities:Full lifecycle management of approved NDAsPreparing and submitting NDA annual reports, post-approval CMC supplementsSubmission activities in eCTD formatProvide regulatory assessments of CMC...
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Director Regulatory Affairs
3 days ago
Abbott Park, United States Abbott Laboratories Full timeWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...
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Senior Manager, Regulatory Affairs
3 months ago
Franklin Park, United States Sun Pharma Full timeCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection – Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on...
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Director Regulatory Affairs
6 days ago
Abbott Park, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...
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Menlo Park, California, United States ReCode Therapeutics Full timeWho We Are:ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...
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Senior Manager, Rates and Regulatory Affairs
3 months ago
Litchfield Park, United States Liberty Utilities Full timePurpose As our Senior Manager of Rates and Regulatory Affairs you will collaborate with the Transformation and Regulatory Teams, contributing to the success of rate case filings across multiple states and commodities. Reporting to the Senior Director, Rates & Regulatory Affairs, you will be instrumental in preparing regulatory materials and supporting...
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Director of Regulatory Affairs
3 months ago
Winter Park, Florida, United States Full Sail University Full timeIf you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewardingThis position will report to the...
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Senior Manager, Rates and Regulatory Affairs
4 weeks ago
Litchfield Park, United States Liberty Full timeOur purpose is sustaining energy and water for life, and it is demonstrated in everything we do as a business, and as an employee team. At Liberty, we hire passionate people who care about doing the right thing for our customers. We are entrepreneurial, creative, and outcome-focused. Here, your natural talent and achievements will flourish in an inclusive...
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Director of Regulatory Affairs
3 months ago
Winter Park, United States Full Sail University Full timeIf you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewarding!This position will...
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Litchfield Park, Arizona, United States Liberty Utilities Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Rates and Regulatory Affairs to join our team at Liberty Utilities. As a key member of our organization, you will play a critical role in collaborating with our Transformation and Regulatory Teams to ensure the success of rate case filings across multiple states and commodities.Key...
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Senior Manager, Rates and Regulatory Affairs
3 weeks ago
Litchfield Park, United States Liberty Full timeOur purpose is sustaining energy and water for life, and it is demonstrated in everything we do as a business, and as an employee team. At Liberty, we hire passionate people who care about doing the right thing for our customers. We are entrepreneurial, creative, and outcome-focused. Here, your natural talent and achievements will flourish in an inclusive...
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Head of Regulatory and Compliance
2 months ago
Menlo Park, United States Octave Full timePioneering Regulatory Leader for Transformative Neuroscience StartupOctave Bioscience is pioneering novel diagnostics, digital solutions, and data-driven analytics to revolutionize care for neurodegenerative diseases. Join our mission to advance groundbreaking products for multiple sclerosis, Parkinson's, and beyond.The Opportunity: As Head of Regulatory and...
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Head of Regulatory and Compliance
1 month ago
Menlo Park, United States Octave Full timePioneering Regulatory Leader for Transformative Neuroscience StartupOctave Bioscience is pioneering novel diagnostics, digital solutions, and data-driven analytics to revolutionize care for neurodegenerative diseases. Join our mission to advance groundbreaking products for multiple sclerosis, Parkinson's, and beyond.The Opportunity: As Head of Regulatory and...