- 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
- 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
- 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational… 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
- 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
- ICON Clinical Research (Farmingdale, NY)
- …and the friendliest people in the sector, and you'll be helping shape an industry. ** Regulatory Affairs Manager - In Vitro Diagnostic (IVD) Medical Devices** ... **The role:** As a Regulatory Affairs Manager you will need to be experienced with In Vitro Diagnostic (IVD) Medical Device and CDx directives, regulation,… more
- ICU Medical (Lake Forest, IL)
- …and will not be discriminated against on the basis of disability. **Title:** * Regulatory Affairs Manager * **Location:** *IL-Lake Forest* **Requisition ID:** ... Job Title Manager , Regulatory Affairs - Electromechanical Devices FLSA Status Exempt Work Arrangement Hybrid Position Summary The Manager , Regulatory … more
- Philips (Orlando, FL)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips Ultrasound. **Your… more
