- Ascendis Pharma (Princeton, NJ)
- …Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . Provide ... for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...Based on timelines or resources, may assist another Global Labeling Lead by managing labeling … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible...of labeling documentation and assures that Takeda labeling content and processes conform to regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either ... immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to...Based on timelines or resources, may assist another Global Labeling Lead by managing labeling … more
- Bausch Health (Bridgewater, NJ)
- … labeling changes + Evaluates content of labeling on all labeling component artwork to ensure compliance with regulatory requirements and company ... and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead , CMC, Graphics, Legal,... process, systems, tools and/or procedures. + Review new labeling for accuracy and for other regulatory … more
- Bausch + Lomb (Bridgewater, NJ)
- …regulatory approval of medical devices. Knowledge of medical device product labeling processes for review and obtaining regulatory approvals. Strong ... LRS Specialist is responsible for the development and maintenance of Labeling Requirements Specification (LRS) templates and product specific content documents.… more
- J&J Family of Companies (Titusville, NJ)
- …of worldwide regulatory guidelines and their applications for guidance for labeling + Experience leading project teams within a matrix environment, combined with ... Experience working in document management systems Preferred Skills: * 3 years of Regulatory Affairs with experience in product labeling / labeling regulations,… more
- J&J Family of Companies (Titusville, NJ)
- …Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling ... worldwide regulatory guidelines and their applications for guidance for labeling . + Experience leading project teams within a matrix environment, combined with… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North ... America Regulatory Lead in Global Regulatory ...critical review of submission documents to ensure compliance with regulatory requirements. + Participates in development of labeling… more
- Bristol Myers Squibb (Princeton, NJ)
- …Align regulatory plans with commercial and development plans + Develop target labeling and co- lead the cross-functional labeling team. + Ensure ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). + Serve as… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory product ... Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be...prioritization, objectives and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling… more
- Bristol Myers Squibb (Princeton, NJ)
- …direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities + Lead regulatory dossier submissions to global ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- J&J Family of Companies (Titusville, NJ)
- …everyone in it. Learn more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead the team in ... access issues (eg, health technology assessments, payor demands) + Lead the preparation of regulatory dossiers for...OUS markets. + Serve as a member of the Labeling Working Group to create or update the CCDS… more
- Sanofi Group (Bridgewater, NJ)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL) , the Regulatory Strategist (RS) leverages their ... study team meetings) + May serve as a regional/local regulatory lead and point of contact with...Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for… more
- Bristol Myers Squibb (Princeton, NJ)
- …execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** + Lead safety activities and ... develop strategy for signal evaluation and document outcome. + Lead safety labeling activities for assigned products/...as the Safety Subject Matter Expert for input to regulatory product labeling . Participate/ Provide input at… more
- Bristol Myers Squibb (Princeton, NJ)
- …assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for indications that are at regulatory ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Novo Nordisk (Princeton, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one... strategy documents + Supervise, review and approval of labeling for marketed products + Track applications through FDA… more
- Bausch + Lomb (Bridgewater, NJ)
- …product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence ... business. * Influence external regulatory stakeholders and shape the external regulatory environment. * Effectively lead /manage projects with the ability to… more
- Bristol Myers Squibb (Princeton, NJ)
- …execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements. **Position Summary** . Lead safety activities and ... as safety sections of relevant clinical trial documents and regulatory filings. . Lead team in the...Develop strategy for signal evaluation and document outcome. . Lead safety labeling activities for assigned products/program.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Clinical Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... Profile (TPP) + Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.)...Health Authority) + Participant and voting member in the labeling development process in the Labeling Working… more