- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer ... Position Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The … more
- Merck & Co. (Rahway, NJ)
- …responsibilities.Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains, with an ability to ... or equivalent regulatory authoring/publishing platforms.Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing,… more
- Terumo Medical Corporation (Somerset, NJ)
- …stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as well as external ... documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators. +… more
- Parexel (Trenton, NJ)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Coty (Morris Plains, NJ)
- Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR MANAGER, US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking for smart ... and defense. This position reports to the Director, NA Regulatory Affairs and R&D Material Management and...retailers. + Provide guidance to Product Development regarding OTC labeling and claims. Including working with the global… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- J&J Family of Companies (Raritan, NJ)
- …a single submission. **Director, Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs ** Are you ready to shape the future of ... a dynamic and visionary leader to join our Cross-Regional Regulatory Affairs team as **Director, Labeling...of the global pharmaceutical landscape, including R&D, regulatory affairs , and commercial strategy. + Minimum… more
- Nestle (Bridgewater, NJ)
- …and nutrition for patients and consumers. **Position Summary:** Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs ... Labeling Lead will be responsible for managing regulatory strategy and material approvals within their areas of...alignment with the overall company strategy. In collaboration with Global Regulatory Affairs leads and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device...prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Sumitomo Pharma (Trenton, NJ)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- Kelly Services (Bridgewater, NJ)
- ** Global Labeling Lead Specialist** Kelly(R) Science & Clinical is seeking a Global Labeling Lead for our client based in Bridgewater, NJ. If you're ... Tampa, FL or St Louis, MO** **Compensation: $45-47.50 hr** **Remote option possible** The Global Labeling Lead is responsible for leading labeling artwork… more
- Mondelez International (East Hanover, NJ)
- …; Know Your Rights: Workplace Discrimination is Illegal **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality, Safety and Compliance ... and provide guidance to business teams and product development on appropriate regulatory compliance and labeling for Over-the-Counter drugs, Natural Health… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Associate Director, Global Regulatory Affairs , you will act as the Regional ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and... Affairs and may serve as Regional Regulatory Lead or Global Regulatory … more
- Parexel (Trenton, NJ)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Bausch + Lomb (Trenton, NJ)
- …+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements. + Provide ... eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and...of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work… more
- embecta (Parsippany, NJ)
- …market new or modified devices in both the US and Europe, and related regulatory affairs activities to ensure compliance with regulations and alignment with the ... embecta is a global diabetes care company that is leveraging its...objectives of the business. This role will also represent regulatory affairs and provide leadership across multiple… more
- Reckitt (Parsippany, NJ)
- …team and allow you to grow in our great organisation. **About the role** The Regulatory Affairs & Safety Associate, Regulatory and Compliance provides ... regulatory team. This position reports to the Regulatory Affairs & Safety Manager, Essential Home....to manage regulatory and compliance approvals (ie regulatory checks, MPL approvals, registrations, labeling , etc.)… more
- Sumitomo Pharma (Trenton, NJ)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... primarily function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sumitomo Pharma (Trenton, NJ)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
