- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- 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
- Haleon (Warren, NJ)
- …**Basic Qualifications:** + BA or BSc Minimum + 5+ years of experience with Regulatory Affairs + 2+ years working specifically in food/dietary supplements + Good ... special. **About the role ** This position has responsibility for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily… 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
- 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 firm-wide ... 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
- American Express (New York, NY)
- …programs and reporting. Corporate Functions Control Management is looking for a ** Manager of Governance, Regulatory Change Management** , focused on ensuring ... multiple partners across numerous business units, functional areas, and geographies. The Manager will primarily be responsible for ensuring regulatory changes… 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
- 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
- JPMorgan Chase (New York, NY)
- …years' experience at a large financial institution, regulator or law firm leading regulatory affairs and/or engagements. + BA/BS or similar degree required. + ... line of business ("LOB") regulatory engagements. Reporting to the Regulatory Engagement Manager ("REM") for Asset & Wealth Management, you will manage the… 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
