- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either ... and immune disorders. SummaryThis 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
- Merck & Co. (Rahway, NJ)
- …final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory ... limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for commercial, Medicaid and ... Supervise external outside counsel.- Serve as a member of Labeling and Pricing Committees and as legal representative on...school experience required- 7 or More Years experience in regulatory , compliance, and legal matters relating to pricing and… 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
- 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 (Raritan, 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 (Raritan, 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
- Merck (Rahway, NJ)
- …that support the Regulatory Affairs group, enabling the seamless integration and labeling of products to ensure compliance with regulatory standards. As the ... the development of guides and documentation for streamlined system processes. + Lead or support Intelligent Integration & Labeling Management projects.… more
- J&J Family of Companies (Raritan, 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
- 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
- Sanofi Group (Morristown, NJ)
- ** Regulatory Compliance and Operations Lead , NA** Location: Morristown, NJ **_About the Job_** Are you passionate about navigating the complex landscape of ... requirements? We have a great opportunity for a Regulatory Compliance and Operations Lead North America....our processes & workflows in areas such as the labeling approval process within NA and Veeva Vault documentation.… more
- Bristol Myers Squibb (Madison, 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
- Mondelez International (East Hanover, NJ)
- …and provide guidance to business teams and product development on appropriate regulatory compliance and labeling for Over-the-Counter drugs, Natural Health ... It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.**...respective categories and geographical area using your Scientific and Regulatory expertise. You advocate for our regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to ... Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo… 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
- Sanofi Group (Bridgewater, NJ)
- …position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative global healthcare company ... In this role you will: + Enable the Global Regulatory Lead (GRL) to provide regulatory...Strategy (GRPS) and ensures alignment with the core product labeling for vaccines in his/her remit. + Participate in… more
