- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance with evolving global regulatory requirements and with company objectives. The Head of GRA Global Labeling leads a team of labeling ... and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, … more
- Sanofi Group (Cambridge, MA)
- …agencies resulting in product approvals or labeling updates. The position reports to Head of Global Labeling Strategy at Sanofi. **MAJOR DUTIES AND ... Neurology Therapeutic Areas and to obtain internal company and regulatory agency approvals. Development of labeling for...Builds and maintains relationships with key stake holders in global regulatory affairs, other R&D and commercial… more
- Philips (Cambridge, MA)
- ** Head of Regulatory Affairs, S&RC** Lead and manage global teams of Regulatory Affairs professionals responsible for all Regulatory activities in ... needs. **Your role:** + Responsible for developing and implementing global regulatory strategy and roadmaps through deep...processes (generally at the BIU and field level), and Labeling Plans for products. + Manage compliance to FDA,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director, Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: Apr 15, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...is done in full compliance with Teva's and all regulatory and governance requirements. The Pipeline Head … more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director, Pipeline Head for Immunology, Global Health Economics, Value, and Outcomes Date: Apr 15, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...studies, surveys, and economic models. The **Senior Director, Pipeline Head for Immunology** , will develop the TA strategies… more
- Sanofi Group (Bridgewater, NJ)
- …grow, enjoy and be at their best._ **Position Summary** Under the supervision of the Global Head of Consumer Safety, the Medical Safety Head (TAH) provides ... Safety + Provide PV expertise within the Company **Key Networking Relationship of Global Sub-Category Head and Their Team** + PV representative to Medical… more
- Sanofi Group (Cambridge, MA)
- …responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well ... Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed.... Regulatory Strategy and Plan, including a global labeling strategy for assigned projects +… more
- Sanofi Group (Cambridge, MA)
- …Responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well ... Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed.... Regulatory Strategy and Plan, including a global labeling strategy for assigned projects +… more
- AbbVie (Boston, MA)
- …expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Director, Global Regulatory Lead, is responsible for developing...the direction of a GRS Sr GRL or TA Head . May participate in or lead regulatory … more
- Vanderbilt University Medical Center (Fontana, CA)
- …University Medical Center:** Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community ... position with expertise in protein chemistry, GLP/GMP manufacturing, antibody chemistry/ labeling , and/or HPLC techniques to directly assist with cGMP production… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head , Regulatory Affairs and ... Regulatory Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that could impact the… more
- Sanofi Group (Cambridge, MA)
- …the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling , product defense, and development projects. Serve ... well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products… more
- Pfizer (New York, NY)
- …Affairs Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature as well as building public & patient ... outcomes research, RW-relevant health informatics, and biostatistics talent from global , international markets into one team to drive efficiency through… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Development, Proof of Clinical Principle, Release of Full Development, input into regulatory strategies and labeling discussions). + Provides medical guidance ... and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …plans and studies and ensure implementation on behalf of the HEOR Functional Head . This position has a 3 day/week on-site requirement in Sleepy Hollow, NY. ... constructive and productive relationships across the Alliance Develop and implement global and regional strategies and programs to inform, support and strengthen… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …progress toward achieving development goals. + General knowledge with cGMP manufacturing, regulatory regulations is preferred. **What you bring to Takeda:** + High ... controlled environment requiring special gowning and wear protective clothing over the head , face, hands, feet and body. This may include additional hearing… more
