- 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
- 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
- Pfizer (New York, NY)
- …+ Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders. Interpersonal and ... verbal communication skills. Technical Skills: + Ability to apply labeling regulatory guidance on formatting requirements. +...and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's… 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
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Global Regulatory Lead , you will be accountable for the development and execution ... Regional Regulatory Liaisons and other colleagues as needed. You will also lead Regulatory Project Teams and represent Inflammation RA as a subject matter… more
- Merck (Rahway, NJ)
- …of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single ... to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy to optimize label and… more
- Bristol Myers Squibb (Madison, 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. **Qualifications** + ... real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance… more
- Bristol Myers Squibb (Madison, 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
- 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