- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... act as the US Reg Intel & Policy regional representative , directly responsible for Reg Intel & Policy activities...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and inspection preparedness for the respective PV inspections in alignment with regulatory and company strategy.Act as the management representative for all ... while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to...align develop the CSPV road map to meet changing regulatory and business needs.Assure a closed loop of PV… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... brand/therapy area strategy and key decisions. US brand/therapy area representative across various NNI governance committees Omnichannel Experience Strategy: Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... reinforcement and ongoing growth of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does not have any direct… more
- Catalent Pharma Solutions (Bloomington, IN)
- **We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana!** Catalent is a ... essential to our mission: to help people live better, healthier lives. The ** Senior Regulatory Affairs Specialist** serves as the liaison to clients and… more
- Stryker (Fremont, CA)
- …(ie global regulatory submissions and registrations) + Serve as a regulatory affairs representative to improve awareness, visibility, and communication ... organization by visiting stryker.com We are currently seeking a ** Senior Staff Regulatory Affairs Specialist** to join our Neurovascular division… more
- Danaher Corporation (Sunnyvale, CA)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Regulatory Affairs Senior Specialist is ... Danaher Business system. This position is part of the Regulatory Affairs - Global Market Expansion Team...and maintain product approvals globally. + Serves as RA representative to gather and interpret new and changed regulations… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist** to join our team on-site in ... applications to achieve departmental and organizational objectives. + Acts as a regulatory representative on core product development teams, communicates … more
- Fresenius Medical Center (Waltham, MA)
- …with 25% travel **PURPOSE AND SCOPE:** Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership, ... existing trends and new initiatives related to state and federal regulatory activities. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Maintains current/high level… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director, Clinical Development & Medical Affairs...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- CSL Behring (King Of Prussia, PA)
- …and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our King of Prussia PA, ... contribute to the vision, goals and improvement of Global Regulatory Affairs and includes collaboration with external...FDA and other health authorities. o Serve as a liaison/ representative for our submission to regulatory agencies.… more
- Ascendis Pharma (Palo Alto, CA)
- …activities and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory ... The Director, Regulatory Affairs will be responsible for...and potential product expansion . Acts as the company representative with regulatory authorities . Prepares and/or… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior Leadership. **About you: To be successful ... **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible...audits, responses, and new submissions, and RA leadership team representative . + Responsible for the global regulatory … more
- ThermoFisher Scientific (Carlsbad, CA)
- …**Discover Impactful Work:** The Senior Manager will work in the Regulatory Affairs department and will establish and implement global regulatory ... cleaner and safer. **Location/Division Specific Information** Thermo Fisher is seeking a Regulatory Affairs professional to join the area of molecular… more
- Sanofi Group (Cambridge, MA)
- …in the Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC Regulatory Affairs representative , work with brands on competitively positioning ... **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The… more
- Amazon (Sunnyvale, CA)
- …Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...medical devices. Key job responsibilities * Acts as a regulatory representative on core product development teams,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and to provide medical education and support, as needed. + Serves as Medical Affairs Representative on USMA development project teams, as assigned. + Provides ... We have an exciting opportunity within our US Medical Affairs team for a Senior Manager, Medical...meetings. + Must be fully aware and compliant with regulatory and legal (Business Conduct) requirements for clinical trials… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- …it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading ... This position will report directly to the Global Director Regulatory Affairs . The person will be responsible...solutions in domestic and global markets. Act as a regulatory representative with internal/external customers, communicating … more
