- 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 ... and life cycle management. This includes development and implementation of regulatory strategies and timelines as well as the preparation of submissions.Essential… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… 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 ... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to...on external regulatory initiatives Works with Group Manager to maintain surveillance of regulatory environment… more
- Aequor (Newbury Park, CA)
- …for inclusion in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under under the direction ... of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory documents. Technical: Proficiency in Microsoft… more
- Aequor (Newbury Park, CA)
- This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone ... Sigma method and project management experience. The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their… 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, ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Aequor (NJ)
- …Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging Vendors, CRO's, IRT ... 100 % remote Manager prefers local candidates (will consider non local...phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery… more
- Merck & Co. (Rahway, NJ)
- …Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality ... regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with… more
- Lundbeck (Chicago, IL)
- …include continuous collaboration with all relevant support departments: marketing, medical affairs , regulatory , IT, sales operations, commercial analytics, etc., ... of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will 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… 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
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, and Legal ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including but not limited investor relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful ... candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree in relevant discipline required Experience Qualifications- 4 or More… 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 ... Are you ready to experiment with us? The Position The Consumer Strategist Manager will be a critical driver in shaping an insights-driven Consumer marketing… more
- Reynolds Consumer Products Inc. (Lake Forest, IL)
- …legislation, and regulation of consumer-packaged goods and the environment.Assist the Senior Regulatory Counsel and Senior Regulatory Manager with developing ... have: High school diploma or equivalent.2-5 years' experience working in regulatory compliance or regulatory affairs for a consumer products, food, beverage,… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleAs a Senior Communications Manager for Fidelity Wealth, you will work directly for the Head Fidelity Wealth Communications supporting the ... standards in the areas of accuracy, ethics, legal, and complianceWorking across Corporate Affairs and with business partners (eg, HR, Strategy & Finance, Product &… more
- Rose International (Rosemead, CA)
- …Rate ($): 32.36 Must Have Skills/Attributes: Analytical Skills, Project Management, Regulatory Affairs , Utility Job Description **Only those lawfully authorized ... or an equivalent e-mail application Desired Skills/Attributes: * Experience with regulatory matters, law, or utility operations * General knowledge of Company… more
- Arthrex (Naples, FL)
- …and coordinates with additional collaborators including product management, statistician, regulatory affairs , clinical research management, and contract research ... Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a… more
- HRPivot (Tucson, AZ)
- …at www.syncardia.com. Position description: SynCardia is looking for an energetic International Regulatory Affairs Manager . The successful candidate will be ... to authorities in SynCardia's international markets. To this end, the International Regulatory Affairs Manager will be working together with Regulatory … more
