Regulatory Affairs Expert
5 days ago
As a Regulatory Affairs Expert at Daiichi Sankyo, you will play a critical role in ensuring the compliance of our products with global regulations and guidelines. This includes managing the development and maintenance of Company Core Data Sheets (CCDS) for assigned products, as well as driving the maintenance of global labeling and associated documents. Additionally, you will lead cross-functional teams through labeling discussions with Health Authorities (HAs) while ensuring management alignment.
Key Qualifications:
We are seeking a highly experienced Regulatory Affairs professional with a strong background in labeling and regulatory affairs. The ideal candidate will have a minimum of 10 years of experience in the pharmaceutical industry, with 4 or more years of direct regulatory affairs experience, including CCDS and US/EU labeling experience. A bachelor's degree in a scientific discipline is required, and an advanced degree is preferred.
Why Daiichi Sankyo:
Daiichi Sankyo is a global pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs. With over 100 years of scientific expertise and a presence in over 20 countries, we offer a unique opportunity to work with a talented team of professionals who share your passion for innovation and excellence. As a Regulatory Affairs Expert at Daiichi Sankyo, you will be part of a dynamic team that is committed to delivering high-quality products to patients worldwide.
-
Regulatory Affairs Labeling Strategy Expert
7 days ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi Sankyo, Inc.Daiichi Sankyo Group is a leading pharmaceutical company with a rich legacy of innovation spanning over 125 years. With a presence in more than 20 countries and a team of approximately 18,000 employees worldwide, we are committed to delivering innovative therapies that address unmet medical needs globally.Salary: $120,000 - $180,000...
-
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeDaiichi Sankyo, Inc. is a global pharmaceutical leader with over 110 years of experience in delivering innovative therapies to improve patient outcomes. We are seeking an experienced Regulatory Affairs expert to join our Global Labeling Operations team as a Global Regulatory Affairs Lead.About the RoleThis role will be responsible for leading the development...
-
Regulatory Affairs Expert
2 weeks ago
San Jose, California, United States San Jose Water Company Full timeAbout San Jose Water CompanySan Jose Water Company, a leading water utility in Silicon Valley, is seeking a highly skilled Regulatory Affairs Analyst to join our team. With over 150 years of experience, we pride ourselves on providing high-quality, life-sustaining water to over 1 million people.Compensation and BenefitsWe offer a competitive annual salary of...
-
Regulatory Affairs Strategist
4 days ago
South San Francisco, California, United States Alumis Full timeAt Alumis Inc., we are driven by a mission to transform the lives of patients with autoimmune diseases. With a focus on precision medicines, our goal is to fundamentally change outcomes for these patients.Job SummaryWe seek an exceptionally motivated individual to provide leadership and support to global regulatory activities, ensuring compliance with health...
-
Scientific Regulatory Affairs Specialist
7 days ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi Sankyo, Inc.Daiichi Sankyo Group is a pharmaceutical company dedicated to creating and supplying innovative therapies to improve healthcare standards globally. With over 100 years of scientific expertise and a presence in more than 20 countries, the company leverages its world-class science and technology to address diversified, unmet medical...
-
Regulatory Affairs Expert
7 days ago
San Diego, California, United States Lifelancer Full timeOverviewCrinetics Pharmaceuticals is a pioneering biotech company dedicated to developing innovative therapies for endocrine diseases and tumors. Our mission is to transform lives through rigorous innovation, patient-centric culture, and a team-oriented approach.We are seeking a highly skilled Manager, Regulatory Affairs to join our team in San Diego, CA....
-
Global Regulatory Affairs Leader
7 days ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi SankyoDaiichi Sankyo Group is a pharmaceutical leader with over 125 years of scientific expertise and a presence in more than 20 countries. We are dedicated to creating innovative therapies that improve standards of care for patients globally.Our company's vision is to become a global pharma innovator with a competitive advantage in oncology,...
-
Regulatory Affairs Specialist
5 days ago
San Diego, California, United States Lifelancer Full timeAbout Us:Becton, Dickinson and Company is a leading global medical technology company that serves healthcare professionals and their patients in more than 190 countries.We are committed to advancing the world of health by developing innovative solutions that improve patient outcomes and enhance the quality of life for people around the world.Job Summary:The...
-
South San Francisco, California, United States AbbVie Full timeCompany OverviewA leader in oncology research and development, AbbVie is committed to discovering and delivering innovative treatments for various types of cancer. Our team works tirelessly to combine expertise in immuno-oncology, stem cells, and cell-signaling with knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor...
-
San Francisco, California, United States Stirling Q&R Full timeJob Title: Regulatory Affairs Director for Pharmaceutical Product DevelopmentAbout Stirling Q&R:We are a leading pharmaceutical company in the San Francisco Bay Area, committed to developing and commercializing innovative therapeutic products. Our dynamic environment offers excellent opportunities for growth and professional development.Job Description:This...
-
Regulatory Affairs Director
7 days ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi Sankyo, Inc.">Daiichi Sankyo Group is a global pharmaceutical innovator dedicated to improving standards of care and addressing diverse unmet medical needs worldwide. With over 100 years of scientific expertise and a presence in more than 20 countries, the company has a robust pipeline of promising new medicines.">Our Vision">Under our 2025...
-
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeGlobal Regulatory Affairs Strategy RoleDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. As a key member of the Daiichi Sankyo team, you will be responsible for providing oversight and formulation of strategy for...
-
Regulatory Affairs CMC Specialist
5 days ago
San Mateo, California, United States Fladger Assoc. Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs CMC Associate to join our team at Fladger Assoc. Inc. in Foster City, CA. This is an exciting opportunity for a professional with a strong background in regulatory affairs and experience in supporting biologic and small molecule drugs.About the RoleThe successful candidate will provide regulatory...
-
Regulatory Affairs Manager
4 days ago
San Diego, California, United States Lifelancer Full timeCompany Overview">Crinetics Pharmaceuticals is a pioneering pharmaceutical company dedicated to developing innovative therapies for endocrine diseases and tumors. Our team of experts is driven by a passion for science and a commitment to improving patient lives.">Salary Range">The anticipated base salary range for this role is $102,000-$136,000 per annum,...
-
Regulatory Affairs Professional
5 days ago
San Diego, California, United States Cypress HCM Full timeAbout Cypress HCMCypress HCM is a leading company in the medical device industry, dedicated to providing innovative solutions for regulatory affairs and product development.
-
Regulatory Affairs CMC Specialist
5 days ago
San Mateo, California, United States Fladger Assoc. Inc. Full timeFladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs CMC Associate to join our team in Foster City, CA.About the RoleThis exciting opportunity offers a competitive salary of approximately $120,000 - $180,000 per year, commensurate with experience, plus benefits.Key ResponsibilitiesProvide Regulatory CMC support for biologic and small molecule...
-
Regulatory Affairs Director
5 days ago
San Diego, California, United States Dennis Partners Full timeCompany OverviewThe clinical-stage biotech company, Dennis Partners, is a dynamic organization focused on developing innovative small molecule therapeutics for the treatment of devastating cancers and immune disorders. With multiple programs in clinical trials and a rapidly growing clinical portfolio, this is an exciting time to join our team as a Vice...
-
Regulatory Investigator Lead
1 week ago
San Diego, California, United States Department of Consumer Affairs Full timeAbout the JobWe are seeking a highly skilled and experienced Regulatory Investigator to lead our investigative team in San Diego. As a key member of our Health Quality Investigation Unit, you will be responsible for overseeing complex investigations and ensuring that our department's regulatory requirements are met.Job SummaryThe successful candidate will...
-
South San Francisco, California, United States Alumis Full timeJob OverviewAlumis Inc. is a pioneering precision medicines company dedicated to revolutionizing the lives of patients with autoimmune diseases. Despite significant advancements in treatment over the last two decades, many patients continue to suffer - our mission is to fundamentally change outcomes for these patients.We are seeking an exceptionally...
-
San Mateo, California, United States Fladger Assoc. Inc. Full timeJob OverviewFoster City, CA - Fladger Assoc. Inc.About the RoleThis Regulatory Affairs Associate position is an excellent opportunity for a detail-oriented professional to join our team in Foster City, CA. The successful candidate will have experience with regulatory compliance and be able to work under deadlines.ResponsibilitiesPrepare Drug Listings/Lot...