- 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)
- Job DescriptionAssociate Principal Scientist Regulatory Affairs - OncologyAt our company, we aspire to be the premier research-intensive biopharmaceutical ... applications.Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead.Participating as an active member on 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
- 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
- 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
- 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
- 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... our teams accelerate progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and… more
- Parexel (Trenton, NJ)
- …of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice + ... you'll be the go-to expert for global labeling , working side-by-side with client teams across Regulatory... labeling , working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial.… 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
- J&J Family of Companies (Raritan, NJ)
- …(GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs ) to ensure the global labeling strategy aligns with ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...primary labeling . + Represent global labeling in Global Regulatory teams… 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
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be...skills including: verbal, reading and writing. + Use various labeling software tools such as TVT and/or Global… 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
