- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs... Operations team by providing guidance, as well as regulatory system and process support for the US ... organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more...and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …true to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** ... meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission...vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …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...MS Project, OnePager, Office Timeline, SharePoint etc). **More about us :** At Takeda, we are transforming patient care through… more
- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary interface… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... biopharmaceutical company with locations in Denmark, Europe, and the United States . Today, we're advancing programs in...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek… more
- Bristol Myers Squibb (Princeton, NJ)
- …etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for the product ... perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners,...which the hired candidate will be working in the US , the salary ranges provided are shown in accordance… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with- us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and ... Labeling + Anticipate and interpret key trends and changes in the global/ US regulatory environment and provide strategic guidance regarding development plans as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex- US … more
- Novo Nordisk (Princeton, NJ)
- … regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager ... The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU… more
- J&J Family of Companies (Titusville, NJ)
- …United Kingdom, Europe/Middle East/Africa- United Kingdom-England-High Wycombe, NA- United States , NA- US -Pennsylvania-Horsham, NA- US -New ... Associate Director , Signal Detection Scientist -...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Temperature Strategy & Execution...in this posting applies to candidates hired in the United States . Candidates hired outside the ... part of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director , Temperature Strategy & Execution within Clinical Supply Chain (CSC).… more
- Bristol Myers Squibb (Princeton, NJ)
- …a dynamic organization that is focused on strategic and executional excellence. As an Associate Director , you will be working among the best in your profession ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...success of training multiple market access field teams. The Associate Director will be responsible for driving… more
- Bristol Myers Squibb (Princeton, NJ)
- …Field Enablement Team, and the WW Centre of Excellence. Specifically, the Associate Director will work in close partnership with colleagues from ... The selected candidate for this position will report into the Director , US Commercialization Learning Hematology/Oncology, with the primary responsibility… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Strategic Sourcing - R&D and Supply Chain/TOQ.** The ... company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada,...Associate Director Strategic Sourcing R&D and Supply… more