- 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)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish company goals.… more
- SSS Company (Atlanta, GA)
- …ointments, creams, tablets. Job Description Our company is seeking an on-site Quality Assurance/ Regulatory Affairs Manager to join our company to oversee ... is detail-oriented, organized, and able to work independently. Primary Responsibilities - Regulatory Affairs Ensures compliance with FDA, EPA and other… more
- Hill's Pet Nutrition (Topeka, KS)
- …and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, ... degree in Policy, Animal/Food Sciences, or equivalent; Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs,… 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 (TX)
- …4 Years of experience minimum (pure medical devise) Support the NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory ... Assessors on Change Notifications, providing a high standard of regulatory support, review and approval of applications with the demonstrated ability to act… more
- Aequor (Thousand Oaks, CA)
- …supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research, ... Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end performance ... standards and adverse event reporting-requirements internally and externally.The Clinical Research Manager (CRM) could be responsible for a particular study for… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …CRD as needed.Works in partnership with GCTO country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country… more
- FirstEnergy Corp (Charleston, WV)
- …West Virginia, with travel as needed and remote work as approved by the manager . The Sr. Advisor, State External Affairs - West Virginia is responsible ... of FirstEnergy Corp. [SC00]The position is within the External Affairs group and reports to the Director, State External...and advocating for FirstEnergy's positions on public policy and regulatory issues that impact the company. The Sr. Advisor… 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
- University Hospital New Jersey (Newark, NJ)
- Responsibilities The Clinic Nurse Manager is an experienced clinical leader responsible for managing assigned areas and multiple services within the assigned ... supervising assigned patient care personnel during clinic operations. The Clinic Nurse Manager is responsible to ensure the safe and effective delivery of patient… more
- Pacer Staffing (Fredericksburg, VA)
- …manage services provided through contractual agreement and vendor relationships in concert with Supply Chain and Regulatory Affairs . . Other duties as assigned. ... systems that facilitate the operations of the anesthesia team while maintaining regulatory compliance and quality patient care. . Develop and monitor performance… more
