- Aequor (Newbury Park, CA)
- …and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory submissions including IND, sIND, BLA, and sBLA ... in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under...under under the direction of a Global or US Regulatory Lead or Manager and will assist… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical , Medical and Regulatory (CMR) department... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to… more
- BioAgilytix (Durham, NC)
- …while you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the ... / clinical trial applications per the requirements of key regulatory agenciesCoordinates regulatory issue resolution using internal resources, regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Merck & Co. (Rahway, NJ)
- …Operations.Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align ... supervision of the TA Head or CRDRequires strong understanding of local regulatory environment. Strong scientific and clinical research knowledge is required.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management of financial budgets and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...and resource strategies within a VP Functional area of Clinical Development, Medical & Regulatory Affairs… more
- Aequor (NJ)
- …development studies during phases 1-4. The individual must partner closely with clinical , regulatory , quality and production associates to ensure timely delivery ... 100 % remote Manager prefers local candidates (will consider non local...Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging Vendors,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, HR, ... and Legal).ResponsibilitiesTraining CommunicationsPlan, create, develop/build, draft and deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological solutions… more
- Tris Pharma (Monmouth Junction, NJ)
- …initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory , and commercial scenarios Prepare clear… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams, including sales, marketing, medical affairs , Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within… more
- Arthrex (Naples, FL)
- …documents and coordinates with additional collaborators including product management, statistician, regulatory affairs , clinical research management, and ... Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills,… more
- University of Colorado (Aurora, CO)
- …practices for areas of responsibility. OCRST Clinical Project Manager , OCRST Regulatory Affairs Manager , OCRST Clinical Monitoring Manager , ... for areas of responsibility. OCRST Clinical Project Manager , OCRST Regulatory Affairs Manager , OCRST Clinical Monitoring Manager , OCRST… more
- AdventHealth (Orlando, FL)
- …alignment with all applicable federal, state, and local rules and regulations. The Sr. Manager Research Regulatory Affairs is responsible for onboarding new ... different regulatory bodies governing research. The Sr. Manager Research Regulatory Affairs has...Affairs has primary responsibility for the Centralized Research Regulatory team, Research Education & Training team, clinical… more
- HRPivot (Tucson, AZ)
- … Regulatory Affairs Manager will be working together with Regulatory Affairs , Quality, R&D, and Clinical Affairs professionals at ... Position description: SynCardia is looking for an energetic International Regulatory Affairs Manager . The successful...regular updates to the Director of Regulatory Affairs and Company management on clinical International… more
- Ascendis Pharma (Palo Alto, CA)
- …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for...regulatory input and support for cross functional (CMC, non- clinical and clinical ) collaboration with other project… more
- Philips (Orlando, FL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new... and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs , and other functions at all… more
- Stryker (Bloomington, MN)
- …quality products and solutions in a timely manner. We are currently seeking a ** Manager , Regulatory Affairs ** to join our **Upper Extremities** **Division** ... **Hybrid** in **Bloomington, Minnesota.** **What you will do** The Manager , Regulatory Affairs (RA) works...of product and clinical safety issues during clinical phases and recommends regulatory solutions. +… more
- Philips (San Diego, CA)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...requirements are determined to go into effect._ + _Providing regulatory support for (pre-) clinical studies, including… more
- Teleflex (Hartford, CT)
- Sr. Clinical Affairs Manager , Interventional Urology **Date:** May 23, 2024 **Location:** Hartford, CT, US **Company:** Teleflex **Expected Travel** : More ... or completeness. 1. Roehrborn, Can J Urol 2017 **Position Summary** TheSr. Clinical Affairs Manager , Interventional Urology delivers professional education… more
