- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... with other therapeutic area leaders and joint Alliance partners.Responsibilities:Lead a multidisciplinary Global Regulatory Team (GRT) to develop global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... Vice President, Human Health and Manufacturing Communications, the Executive Director , Vaccines Communications is responsible for the development of strategic… more
- Merck & Co. (Rahway, NJ)
- …audits to investigate frequent field alerts, recalls, rejects and complaints.Support in informing Senior Management of emerging regulatory and PV trends to help ... aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... area leaders and joint Alliance partners. **Responsibilities:** + Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and new people to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides ... Sr Director , Global Regulatory Medical...Sr Director , Global Regulatory Medical Writing & Data...strategic, scientific, regulatory , and commercial goals. The Senior Director will also: + offer clear… more
- Merck (Rahway, NJ)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- S&P Global (New York, NY)
- …exchange of regulatory data and documentation. The team collaborates with global regulatory bodies, including ISDA, to support protocols for Dodd-Frank, ... Level (for internal use):** 12 **_The_** **_Role:_** **_Regional Commercial Associate Director - Regulatory Compliance_** **The Team:** This commercial position… more
- AbbVie (Florham Park, NJ)
- …needs. Presents process, strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for setting… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution. + ... Participate in global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day regulatory activities. + Continuing… more
- Citigroup (New York, NY)
- Global Rates Middle Office Operations Senior Manager is a senior management level position responsible for accomplishing results through the management of ... the Global Rates Middle Office and Corporate Treasury Operations team...and ensuring the teams have effective risk management and regulatory processes in place. This role requires a strategic… more
