- System One (Florham Park, NJ)
- Senior Manager , Regulatory Affairs (BRANDED PRODUCTS) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview The ... Contractor - Senior Manager , Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory … 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… more
- Insight Global (Florham Park, NJ)
- Job Description Insight Global is seeking a Sr. Manager of Regulatory Affairs to join one of our pharmaceutical clients in Florham Park, NJ. This position is ... for assisting with the development and execution of regional regulatory strategies for the Quality of Life (QOL) division....working with therapeutics and possesses a strong knowledge of regulatory requirements for Phase 1, 2, and 3. This… more
- Hackensack Meridian Health (Hackensack, NJ)
- …of positive change. Within the HMH Office of Research Administration, the ** Manager , Research Credentialing and Regulatory Affairs ** evaluates, analyzes, ... protocols. **Responsibilities** A day in the life of a ** Manager , Research Credentialing and Regulatory Affairs...life of a ** Manager , Research Credentialing and Regulatory Affairs ** at **Hackensack Meridian** **_Health_** includes:… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the ... Manager of Regulatory Affairs to create and collate product master files (dossiers), drug master files (DMF). + Generate and Review of Product CoCs, CoAs,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Support CMC development activities from a regulatory standpoint during early phase, development, submissions and post market requirements for gene therapies. **A ... in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate risks +… more
- Merck (Rahway, NJ)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...achieve optimal results with limited day-to-day direction from the manager . **Preferred Experience and Skills:** + Substantial experience in… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …with both medical devices and in vitro diagnostics. **Program Overview:** BD's Regulatory Affairs internship position is designed to attract highly motivated ... acquire practical work experience relevant to a career in Regulatory Affairs (RA). As a summer intern,...and exciting work. You will work directly with a manager in your day-to-day role and be assigned mentors… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +...one. Please ensure you have discussed with your current manager the intent of applying to a new role.… more
- LS Power Development, LLC (East Brunswick, NJ)
- …parental leave and more. **About the Role:** We currently have an opportunity for a Manager /Director of Government Affairs that can be based in our New Jersey or ... and advocacy strategies.As a member of LS Power's government affairs team, you will be responsible for designing and...in which we operate assets. + Develop legislative and regulatory strategies that are clearly aligned with business +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …us. Reporting to the US Medication Delivery Solutions (MDS) Director of Medical Affairs , the Regional Medical Science Liaison will be responsible to provide medical, ... support to customers + Provides clinical acumen to support the public affairs /market access/government affairs teams for market development activities + Provides… more
- City National Bank (New York, NY)
- **DIRECTOR BUSINESS AFFAIRS ** **WHAT IS THE OPPORTUNITY?** This position provides overall management of significant City National Rochdale (CNR) projects on a ... the firm's activities ensuring that legal issues, contracts, disputes, and complex regulatory and operational risk activities are conducted within the due diligence… more
- Veterans Affairs, Veterans Health Administration (Brooklyn, NY)
- …Analyst is in the HPE Office and is supervised by the HPE Manager with oversight provided by the Associate Chief of Staff/Education, Designated Education Officer ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more
- Veterans Affairs, Veterans Health Administration (Bronx, NY)
- …Substance Use Disorder (SUD) initiatives. - Collaborate with the SRS Program Manager and other leaders to ensure seamless coordination of SUD services across ... disorders. Administrative and Compliance Responsibilities: -Ensure compliance with all regulatory requirements, including documentation standards, accreditation, and federal and… more
- RWJBarnabas Health (Somerset, NJ)
- Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health ... the Department through establishing, tracking project milestones and coordinating submissions. Manager assists in obtaining regulatory approval for enterprise… more
- conEdison (New York, NY)
- …projects, systems implementation and process documentations Required + Demonstrated experience in regulatory program management, regulatory affairs , or a ... (Tableau, Power BI, SAS, Qlik or related) Preferred + Experience in regulatory compliance, auditing, governance or quality assurance Preferred + Using and/or… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …Education A Bachelor's degree or equivalent experience in Environmental Science, Chemistry, Regulatory Affairs , Industrial Safety, or a related field is ... regulations and appropriate qualifications. + Certification in hazardous materials handling or regulatory affairs is a plus. **Knowledge, Skills, Abilities** +… more
- System One (Florham Park, NJ)
- …+ Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance in a ... meetings to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across regulatory… more
- Kedrion Biopharma (Fort Lee, NJ)
- …+ In-depth knowledge of US pharmaceutical market which includes experience working with regulatory affairs , medical affairs , finance, and promotional review ... The **Marketing Manager for US Immunoglobulins (Ig)** will be responsible...to be consistent with Kedrion's corporate guidance and all regulatory , legal, ethical SOPs + Ensures that marketing plans… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more