- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets will be responsible for providing ... Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs, Growth...the employment eligibility of all new hires in the United States . Please click on the following… more
- Lundbeck (Deerfield, IL)
- …- open to candidates in the greater United States ** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and ... Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is… more
- Takeda Pharmaceuticals (Boston, MA)
- …will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - Oncology TAU ... within our Global Regulatory Affairs organization, based remotely. Partners...MS Project, OnePager, Office Timeline, SharePoint etc). More about us : At Takeda, we are transforming patient care through… more
- Insmed Incorporated (NJ)
- …( US , EU, and/or other international markets)Strong knowledge of global regulatory requirements and submission formats (eCTD)Proven experience managing ... future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible...US FDA. The GRL will be accountable for regulatory submissions, communications, and negotiations with global … more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement ... and influencing the field as applicable. Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Eisai, Inc (Bethesda, OH)
- …budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate ... and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable...the employment eligibility of all new hires in the United States . Please click on the following… more
- Eisai, Inc (Nutley, NJ)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project...the employment eligibility of all new hires in the United States . Please click on the following… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration...registration and life cycle support and the leadership of regulatory strategy for projects that are currently US… more
- Merck & Co. (Rahway, NJ)
- …of excellence.Description:-Under the direction of the GTD Director , the Associate Director will be responsible for developing multiple global brand name ... optimize and obtain trademark approval in time for health authority submissions.Leads regulatory submission and rejection strategies for global , regional, and… more
- S&P Global (New York, NY)
- …VBA), R or Python. Compensation/Benefits Information: (This section is only applicable to US candidates) S&P Global states that the anticipated base ... About the Role: Grade Level (for internal use): 13 Director - Review Officer, Corporates & Infrastructure - S&P...(EEO Job Group) (inactive), 20 - Professional (EEO-2 Job Categories- United States of America), RSKMGT202.2 - Middle… more
- Boehringer Ingelheim (Athens, GA)
- …Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global development projects and provide ... subteams. Serve as Subject Matter Expert on the current US regulatory environment and potential trends. Recommend...Requirements: Must be legally authorized to work in the United States without restriction. Must be willing… more
- Bristol Myers Squibb (Princeton, NJ)
- …goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . Associate Director Commercial Regulatory Affairs Description ... : The role of Associate Director of US Commercial Regulatory Affairs requires the ability...Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and external audit program.Schedule, execute, report and follow-up on internal and US and Global external audits (travel required).Ensure audit observations are ... Legend Biotech is a global biotechnology company dedicated to treating, and one...quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical… more
- BeOne Medicines (San Mateo, CA)
- …business partners regarding development, regulatory , and registration strategies within the US and Canada. The Director will also provide line management, ... General Description: The Director , Regulatory Affairs will be responsible...line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders.… more
- Wolters Kluwer (Coppell, TX)
- As the Director of Product Software Engineering for our Legal & Regulatory US business, you will be at the forefront of shaping the technology vision for a ... for innovation and quality. Lead Engineering Excellence: Oversee a global team of engineers across the US ...role in achieving our mission to revolutionize the legal, regulatory and compliance content, expert solutions and software space.… more
- J&J Family of Companies (Spring House, PA)
- …Biomarkers Job Category: People Leader All Job Posting Locations: Cambridge, Massachusetts, United States of America, Spring House, Pennsylvania, United ... in clinical trials for assigned programs. Ensure compliance with global regulatory requirements, ICH GCP, GLP, and...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Valvoline Global (Lexington, KY)
- …how we engage with our partners, customers, and the communities we serve. At Valvoline Global , we are united in our commitment to: - Treating everyone with care. ... operations. This includes oversight of executive protection, facility security, global travel risk management, regulatory compliance, crisis response,… more
- GE HealthCare (Chicago, IL)
- …GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the ... of industry trends that may influence work. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives… more
- GRAIL (Boise, ID)
- …GRAIL products with the FDA and/or global health authorities. Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, ... with locations in Washington, DC, North Carolina, and the United Kingdom. It is supported by leading global...including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device… more
- SMBC (Jersey City, NJ)
- …impact of new products or specific transactions. The ideal candidate will have strong knowledge of US GAAP, US Regulatory Rules as well as the BCBS ... portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will...with detailed rationale. + Demonstrate deep technical knowledge of US regulatory rules, including capital requirements across… more
