- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …interacts with other therapeutic area leaders and joint Alliance partners. **Responsibilities** + Lead a multidisciplinary Global Regulatory Team (GRT) to ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … regulatory strategy is endorsed by GPT and other governance bodies. + Serve as a leader of the GRT ( Global Regulatory Team) + The primary point of ... and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects....or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- Bristol Myers Squibb (Princeton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- J&J Family of Companies (Titusville, NJ)
- …& Johnson Innovative Medicine is recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs, supporting programs ... Associate Director , North America Regulatory Lead...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …. **Position Summary** **The Associate Director - Site Planning Global Process Leader (GPL) will be responsible for ensuring Internal ... the impacted functional teams that will deliver continuous value add initiatives.** ** Lead the delivery of digital first process enhancements to continuously improve… more
- Bristol Myers Squibb (Princeton, NJ)
- …teams on practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for biologics pipeline ... of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with...to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Summary:** The Director of Pricing and Market Access Strategy Lead will be responsible for the overall Global Market Access (GMAx) ... medical, regulatory , clinical, advocacy, policy, business Insights & analytics global leads), and with the relevant individual market stakeholders across the… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- J&J Family of Companies (Titusville, NJ)
- …and SharePoint **Preferred:** * Experience at Health Authority * Understanding of the global regulatory environment, including in US, EU, and AP The anticipated ... Director , Regulatory Policy and Intelligence Research...Policy & Intelligence Research Coordinator will be a key leader in the Policy team, helping the group deliver… more
- Taiho Oncology (Princeton, NJ)
- …Summary: Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, ... Associate Director , Regulatory Affairs Operations Pleasanton, CA,...contract review and negotiation. + Strong working knowledge of global regulatory requirements and submission processes. +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Bristol Myers Squibb (Princeton, NJ)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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
- J&J Family of Companies (Raritan, NJ)
- Director , Global Strategic Marketing, Lung Cancer - 2406211203W **Description** Johnson & Johnson Innovative Medicine is recruiting for a second Director , ... our people can reach their potential. At Johnson & Johnson, we all belong. The Director , Global Strategic Marketing, Lung Cancer reports to the Sr. Director ,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … education, and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... Summary This position will be the Clinical Science Group Lead in late phase development in the Global...multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science… more