- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and… more
- Parexel (Trenton, NJ)
- …* Deep understanding of regulatory requirements for drug development, global labeling , and post-marketing. * Strong problem-solving skills with the ... across multiple therapeutic areas. * Gain exposure to advanced regulatory systems and global labeling strategies. * Competitive compensation, benefits, 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)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… 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)
- ** Regulatory Affairs Specialist Labeling ** Kelly(R) Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based ... approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including… 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
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The role of Associate ... Director of US Commercial Regulatory Affairs requires the ability to apply...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and improving the lives of patients for generations to come. As an Associate Director, Global Regulatory Affairs , you will act as the Regional Regulatory ... 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
- Oracle (Trenton, NJ)
- …across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… more
- Stryker (Mahwah, NJ)
- …launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones ... **Senior Manager, Regulatory Affairs - Joint Replacement Division**...provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals… 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
- 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
- GRAIL (Trenton, NJ)
- …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 ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll...are established and maintained. + Provides input into the global organization for labeling strategies of marketed… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Regulatory Affairs Global Regulatory Strategy is ... therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
