- 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
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… more
- Sanofi Group (Morristown, NJ)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research and… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... role and can be located in Raritan, NJ; Titusville, NJ; Horsham, PA. The Associate Director , Global Labeling Product Leader will be responsible for the… more
- IQVIA (New York, NY)
- **MSL Associate Director ** We are excited to announce that currently we are looking for **Medical Science Liaison Associate Director and Player-Coach** ... contribute clinical insight to inform decision making on various aligned teams. The **MSL Associate Director & Player Coach** will have all of the functional… more
- AbbVie (Florham Park, NJ)
- …Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Statistics - Eye Care provides statistical leadership… more
- Merck (Rahway, NJ)
- …Description** **Role Summary** + Under 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
- 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
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director… more
- Grifols Shared Services North America, Inc (New York, NY)
- …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
- City of New York (New York, NY)
- …30-30 Thomson Avenue, NY, 11101 Only candidates who are permanent in the Associate Project Manager title, reachable on DDC's Promotional Exam #3573, or the Open ... of Design and Construction, Division of Infrastructure is currently seeking a Deputy Director to join the Wetland team. Successful candidate will report to the … more
- City of New York (New York, NY)
- …teams involved in critical areas like drug-resistant TB case management and regulatory affairs . This position requires a highly organized, detail-oriented, and ... take clear and concise meeting minutes. - Assist the Regulatory Affairs Coordinator: Support the preparation and...the job application or interview process, contact Sye-Eun Ahn, Director of the Office of Equal Employment Opportunity, at… more