- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory ... provides planning and drives coordination of global and US regulatory activities. The Associate Director ...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Sumitomo Pharma (Trenton, NJ)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs ** . 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… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Sumitomo Pharma (Trenton, NJ)
- …. **Job Overview** Associate Director , Field Medical and Scientific Affairs ... summarizes, and disseminates key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner. + Participate in the… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 ... TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for Associate Director , RA Submissions. The position can be located on-site/hybrid in the US (Titusville, NJ; ... Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in … more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally,… more
- Novo Nordisk (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare...of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty...global communications programming in support of clinical data and regulatory milestones as well as pipeline; 2) supporting development… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director , Consumer Marketing - US Rare Hematology **Location** : Cambridge, MA **_About the Job_** This role will drive consumer ... disorder. This position is based in Cambridge, MA and will report into Director of Consumer marketing for rare hematology. We are an innovative global healthcare… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- J&J Family of Companies (Titusville, NJ)
- This position will report to the Director , Medical Information Scientific Engagement (MISE) and will have responsibility for providing direct oversight of the ... Essential Functions: + Serves as a strategic partner with internal Scientific Affairs colleagues to find opportunities for outstanding service delivery and leads all… more
- AbbVie (Branchburg, NJ)
- …Key Stakeholders: PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs , Discovery, Clinical Operations Additional Information Applicable ... or Development Safety Update Report) for early development assets *Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV… more
- Novo Nordisk (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Senior Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential Functions + Innovation and change… more