- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the ... within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report...programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development, approval and… more
- Eisai, Inc (Nutley, NJ)
- …regulatory / non- regulatory change review and change management process.Team Leadership: Lead the global teams in the execution of Risk and Compliance ... your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead...Director, IT Security, Compliance, & Architecture, s/he is the Global IT department's trusted leader and manager… more
- Merck & Co. (Rahway, NJ)
- …keeping up with the latest regulatory guidelines and trends.Collaborate with global regulatory teams to align strategies and ensure submission readiness in ... regulatory Chemistry, Manufacturing, and Controls (CMC) content for global submissions, ensuring adherence to international regulatory requirements.Primary… more
- Merck & Co. (Rahway, NJ)
- …report to the Vice President and Global Commercial Leader , Infectious Diseases, Neuroscience & Ophthalmology.Primary Responsibilities: Lead the development ... currently recruiting for an Associate Vice President (AVP) to lead global marketing for our Global...input on activities such as target product profile development, global regulatory filing strategy, launch readiness reviews,… more
- Genmab (Plainsboro, NJ)
- …serious diseases. From our people who are caring, candid, and impact-driven to our business , which is innovative and rooted in science, we believe that being proudly ... oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned… more
- Merck & Co. (Rahway, NJ)
- …competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized ... with cross-functional partners including research and development, medical affairs, regulatory affairs, manufacturing, Business Development & Licensing, market… more
- Merck & Co. (Rahway, NJ)
- … business needs, which can include impact of the external business , regulatory , and compliance environment. Promoting our company's scientific excellence ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate… more
- Merck & Co. (Rahway, NJ)
- …GMP investigations and deviation (OOS & OOT) management.Strong knowledge of current global regulatory standards and best practices related to all aspects ... product presentations and be familiar with current industry and regulatory standards/best practices and innovative approaches for demonstration of container-closure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... diseases and immune disorders. We are currently seeking a Global Internal Audit Intern for the year (June 2025...audit plan and JSOX testing as directed by the leader of Internal Audit which consists of:Executing of Financial,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience (UDX) strategies. In this position, the Non-Regulated Implementation Services Lead will collaborate closely with cross-functional Global DX teams, ... the team in the adoption of innovative technologies and practices. Additionally, the Lead collaborate with business teams, help support in the creation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and to coordinate the execution of the long-term strategy, defining a sustainable business model in US beyond a 5-year time horizon. This department serves as ... therapeutic areas, new products in the pipeline, and products acquired through business development efforts in existing and new areas. The STARS team collaborates… more
- Merck & Co. (Rahway, NJ)
- …Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.-Key leadership skills required for ... of documentation and deviation investigations, ensure permanent inspections readiness, regulatory inspection support and monitoring, change control oversight and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies (FDA, EMA, MHRA, etc.) related to CSPV. Participates ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/ Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… 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 ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… 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 ... level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and...under the RDPV QA functionMust have proven ability to lead and influence others within a global /matrix… more
