- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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
- Merck & Co. (North Wales, PA)
- …five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years ... in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical… more
- Merck & Co. (Rahway, NJ)
- …and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical ... are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in Liquid… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be… 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
- AbbVie (Cambridge, MA)
- …onsite) in Cambridge, MA preferred. Will consider remote candidates. Purpose: The Associate Scientific Director, Psychiatry Pipeline role provides medical and ... scientific strategic and operational input into core medical affairs activities such as: Securing insights, developing scientific value, advancing pipeline… more
- AbbVie (Cambridge, MA)
- …per week onsite) in Cambridge, MA preferred. Will consider remote candidates. The Associate Scientific Director provides medical and scientific strategic and ... discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison with other corporations when… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations...+ Ability to read, analyze, and interpret global regulations, scientific and technical journals and legal documents. + Ability… more
- ICU Medical (Southington, CT)
- …minimum of two years of experience in Medical Products Industry in Regulatory Affairs . . Able to assess scientific arguments and apply analytical and logical ... sales or regulatory action letters. . Follows scientific arguments, identifies regulatory scientific ...be discriminated against on the basis of disability. **Title:** * Associate II, Regulatory Affairs * **Location:**… 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
- Schrodinger (Cambridge, MA)
- We're seeking an ** Associate Director of Regulatory Affairs ** with expertise in hematology and oncology to join our Early Clinical Development team in New ... MA. This hire will report to the Director of Regulatory Affairs and will play an essential...to the FDA and/or EMA + Integrate the European regulatory , legal, scientific /medical and business perspectives to… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. Note: Higher education… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
