- Abbott (Santa Clara, CA)
- Title : Regulatory Affairs Associate Location : Santa Clara, CA Duration : 12 Month 100% Onsite Description / Summary : We are seeking a highly skilled and ... experienced Regulatory Affairs Operations Specialist to join our Regulatory Affairs Operations team. The position will be responsible for designing,… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …bring different and innovative ways of seeing the world and solving problems. The Senior Regulatory Affairs Associate works with faculty and staff in the ... liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of new impacts/areas of knowledge and … more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … 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 ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director, Global Medical Affairs Training and Education is from… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …care, be real, get it done, and have fun, seriously. POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects ... in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs , experience with major Health Authority (US FDA, Health Canada, and EMA) is… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewDedicated, knowledgeable, responsible/ reliable employee who can work in a fast-pace warehouse environment.… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director...us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and execute… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …global drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for marketed products and compounds in ... three days per week on average. Position Summary The Associate Director, Regulatory CMC, is responsible for...least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the ... necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders.… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us. The Associate Director, WW Medical Cell Therapy Autoimmune, LCM/Pan-Indication, will report ... When appropriate, they will also support the execution of BMS sponsored Medical Affairs trials, and assist in the evaluation and support of collaborative and… more
- AbbVie (North Chicago, IL)
- … compliance, and contributes to the overall success of drug/device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the ... for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie's evolved business strategy are complex,...R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight… more
- Eli Lilly and Company (Washington, DC)
- …leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers Engage in forums that share regulatory ... and improve efficiency in drug development. The purpose of the Associate Director - Global Regulatory Policy & Strategy is to support multiple policy campaigns… more
