- Bausch Health (Bridgewater, NJ)
- …creates it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + ... areas centered around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …2 years of experience. **Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in the United States (non-California), is ... insights to internal stakeholders 12. Partner with patient advocacy, regulatory , HEOR, and market access to support US and...**For California:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Generalist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Generalist** **for** our client a leading medical device ... for accuracy and inconsistencies. + Comprehensive knowledge of pharmaceutical regulatory affairs , including Development, Labeling, and post-market requirements.… more
- Canon USA & Affiliates (Trenton, NJ)
- … Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs , the Regulatory Affairs Specialist ... Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry...industry required + Minimum Education Level: 2 Year / Associate 's Degree + 4 Year/ Bachelor's Degree (STEM) preferred… more
- Novo Nordisk (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs...and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** + Understanding… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director (AD) for US Medical Pulmonary will provide deep disease ... communication tools. + Partner closely with colleagues in Discovery, Clinical Research, Regulatory , and Health Outcomes to ensure the science of the pipeline… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . Position reports to the Executive Director , Portfolio Strategy within WW Medical Cardiovascular & Immunology (CV ... & I) Global Medical Affairs and is Responsible for supporting relationship management and...in alignment with therapeutic area strategies developed by the Director , Professional Societies and m edical teams +… more
- Haleon (Warren, NJ)
- …supplements. In line with a risk-proportionate framework for product vigilance, the ** Associate Director , Consumer Safety Science** is accountable for developing ... experience of product safety related disciplines (eg, clinical development, medical affairs , regulatory ) preferred. + Professional qualification as healthcare… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director , TLL, Renal Rare Disease, is a field-based, customer facing, non-sales position on Otsuka's Rare Renal team focused on enhancing and ... The TLL will work closely with cross-functional leaders from Marketing, Medical Affairs , Sales, Key Accounts, Market Access, Patient Access and the Renal Leadership… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Liaisons to ensure successful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents ... clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions. + Contributes to… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …and academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director is typically ... While not essential, prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced understanding of drug… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and/o academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 ... While not essential, prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced understanding of drug… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... in more than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to upcoming clinical trials,… more