- Pentax Medical (Montvale, NJ)
- …requirements. + Support International product registrations. Requirements of Senior Regulatory Affairs Specialist : + Bachelor's degree in Life Sciences ... solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We...FDA regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices +… 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 ... **Are You Ready to Make It Happen at Mondelēz International ?** **Join our Mission to Lead the Future of...Pride.** The Sr. Scientist II will execute the Scientific Affairs Strategy for your respective categories and geographical area… more
- Ascendis Pharma (Princeton, NJ)
- …working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an internal expert on ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for providing… 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 ... of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions....to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- GRAIL (Trenton, NJ)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Stryker (Mahwah, NJ)
- **Senior Manager, Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager, Regulatory Affairs ** , you ... new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improving the lives of patients for generations to come. As an Associate Director, Global Regulatory Affairs , you will act as the Regional Regulatory Lead on ... role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled in either Foster City,… more
- Sanofi Group (Morristown, NJ)
- …committees **About You** This position requires an experienced regulatory affairs professional with familiarity with international submissions from within a ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are… more
- Roche (Branchburg, NJ)
- …more time with the people we love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, ... working closely with colleagues in other departments and other counties. As a Regulatory Affairs Manager focused on Companion Diagnostics (CDx), with specific… more