- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in scientific / regulatory fields required- Experience in international Regulatory Affairs - CMC preferred Daiichi Sankyo, Inc. is an equal ... Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical… more
- Merck & Co. (North Wales, PA)
- …and Real-World Evidence, Global Discovery, Preclinical and Translational Medicine, Global Medical and Scientific Affairs , and Global Regulatory Affairs ... Job DescriptionDescription: The Associate Principal Scientist, Oncology Publications Medical Writing, works with scientists in our company's Research Labs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Adecco US, Inc. (St. Louis, MO)
- An Associate Regulatory Scientific Affairs - Summer Intern (hybrid) is available through Adecco Medical & Science. In this role, you will be responsible ... Collaborate with the claims team (PTC Applied Nutrition scientists and Regulatory & Scientific Affairs ) to understand document requirements and ensure… more
- AbbVie (Mettawa, IL)
- …sponsored or supported clinical research activities. + May oversee the work of Assistant/ Associate Scientific Directors + May lead cross functional teams in ... scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients,… more
- AbbVie (Mettawa, IL)
- …with field execution and leadership + May oversee the work of assistant or associate scientific directors working on different HCV related medical projects + ... title will be based on qualifications listed below. Leads team of scientific /medical directors and responsible for development and execution of medical strategy for… more
- Astellas Pharma (Northbrook, IL)
- …should be elevated to upper management for further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that ... promotion review processes are compliant with approved company procedures. Represents Regulatory Affairs in cross-functional initiatives such as committees,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Thursday, May 30, 2024 Looking for a chance to make a ... post marketing and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the … more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC..., APAC (Asia Pacific) is to combine knowledge of scientific , regulatory and business issues to enable… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory ...+ Minimum BA or BS required, preferably in a scientific or health related discipline. + Minimum 10 years'… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on...+ Develop solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business… more
