Senior Regulatory Affairs Associate Jobs in Edison, NJ

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Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities: -Authoring US FDA 510(k) submission using eSTAR submission tool.

Global Regulatory lead - Associate Director

Dizer Corp

Millburn, New Jersey, USA

Contract, Third Party

Title - Global Regulatory Lead - Associate Director Location - Short Hills, NJ Develop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic dir

CMC 2 Regulatory affairs

Hectadata LLC

Jersey City, New Jersey, USA

Contract, Third Party

Greetings from Hectadata, LLC. We are hiring for the position of CMC 2 Regulatory affairs Please find the below Job Description. If you are interested in this position, kindly submit your applications via Dice. Job Title: CMC 2 Regulatory affairs Location: JFK Parkway, NJ Job Description: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with

Regulatory & Medical Affairs - Project Manager

Net2Source Inc.

Lawrence Township, New Jersey, USA

Contract

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.Job Description: Onsite full time at Princet

Regulatory & Medical Affairs - Project Manager

Sunrise Systems, Inc.

Lawrence Township, New Jersey, USA

Contract

Job Title: Regulatory & Medical Affairs - Project Manager Job ID: 24-01565 Location: Lawrence Township, NJ, 08648 Duration: 06 Months contract on W2 Onsite full time at Princeton Pike. Innovation and Digital Health, Project Manager - Digital Optimization Initiatives Position Summary The Innovation Lab team partners with R&D stakeholders to design and deliver innovative analytics solutions that help them make better decisions, reduce costs and/or drive efficiencies. Our diverse analytics team of

CMC 2 Regulatory affairs Specialist

Dizer Corp

Remote

Contract, Third Party

Job Title: CMC 2 Regulatory affairs Specialist Location: Remote Description: Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment

Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for a remote based opportunity to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents. Support document workf

Sr. Counsel, Business & Legal Affairs

NBC Universal

New York, New York, USA

Full-time

Company Description We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, NBC Local Stations, Bravo, USA Network, and Peacock, our premium ad-supported streaming service. We produce and distribute premier filmed entertainment and programming through Universa

Sr Data Analyst - Non-Financial Regulatory Reporting

Bank Of America

New York, New York, USA

Full-time

This role will serve as a AMRS Regulatory Reporting Manager responsible for driving key reporting activities and functions within the Global Markets NFRR team. Required Skills : Bachelor's Degree with minimum 5+ years of Banking experience; Professional qualifications (CPA) preferred Global Markets, Risk/Compliance Operations and regulatory reporting experience Ability to provide clear oral and written communication to a variety of business and technical audiences. Regulatory Reporting and anal

Associate Director-Full Stack (Sr Mgr-App Dev)

Verizon

Bernards, New Jersey, USA

Full-time

When you join Verizon Verizon is one of the world's leading providers of technology and communications services, transforming the way we connect around the world. We're a human network that reaches across the globe and works behind the scenes. We anticipate, lead, and believe that listening is where learning begins. In crisis and in celebration, we come together-lifting up our communities and striving to make an impact to move the world forward. If you're fueled by purpose, and powered by persis

(Senior Manager) Associate Digital Product Manager, Finance, Commercialization & Enabling Functions

Genmab

Princeton, New Jersey, USA

Full-time

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Opportunity:

(Senior Manager) Associate Digital Product Manager, Finance, Commercialization & Enabling Functions

Genmab

Princeton, New Jersey, USA

Full-time

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Opportunity:

Senior Associate, Clinical Quality Review

Headway

New York, New York, USA

Full-time

Headway's mission is a big one - to build a new mental health care system everyone can access. We've built technology that helps people find great therapists with the first software-enabled national network of providers accepting insurance. 1 in 4 people in the US have a treatable mental health condition, but the majority of providers don't accept insurance, making therapy too expensive for most people. Headway is building a new mental healthcare system that everyone can access by making it easy

Senior Associate, Clinical Quality Education

Headway

New York, New York, USA

Full-time

Headway's mission is a big one - to build a new mental health care system everyone can access. We've built technology that helps people find great therapists with the first software-enabled national network of providers accepting insurance. 1 in 4 people in the US have a treatable mental health condition, but the majority of providers don't accept insurance, making therapy too expensive for most people. Headway is building a new mental healthcare system that everyone can access by making it easy

Compliance - Quant Modeling Associate Senior - Associate

JPMorgan Chase & Co.

Jersey City, New Jersey, USA

Full-time

Bring your expertise to JPMorgan Chase. As part of Risk Management and Compliance, you are at the center of keeping JPMorgan Chase strong and resilient. You help the firm grow its business in a responsible way by anticipating new and emerging risks, and using your expert judgement to solve real-world challenges that impact our company, customers and communities. Our culture in Risk Management and Compliance is all about thinking outside the box, challenging the status quo and striving to be best

Senior Associate, Clinical Engagement

Headway

New York, New York, USA

Full-time

Headway's mission is a big one - to build a new mental health care system everyone can access. We've built technology that helps people find great therapists with the first software-enabled national network of providers accepting insurance. 1 in 4 people in the US have a treatable mental health condition, but the majority of providers don't accept insurance, making therapy too expensive for most people. Headway is building a new mental healthcare system that everyone can access by making it easy

Senior Market and Product Expansion Associate - Concourse

JPMorgan Chase & Co.

Brooklyn, New York, USA

Full-time

Unlock your potential and dive deep into market analytics and product compliance. Harness your expertise to build pivotal relationships, identify areas of improvement, increase efficiencies, and lead our products to their launch. As a Senior Market and Product Expansion Associate in Commercial Banking Solutions, you contribute significantly to your team's success and test the regulatory requirements for our products. You work across the organization, build critical relationships, and prepare the

Admissions and Campus Solutions SIS Production Support Engineer (IT Senior Associate 3)

CUNY Central Office

New York, New York, USA

Full-time

Job Title: Admissions and Campus Solutions SIS Production Support Engineer (IT Senior Associate 3) The City University of New York (CUNY)'s Office of Computing and Information Services (CIS) is seeking an Admissions & Campus Solutions SIS Production Support Engineer who, reporting to the PeopleSoft Finance Solutions Manager, possesses solid experience with PeopleSoft's Financials and Cash Management modules. The incumbent will be a techno-functional application support specialist responsible fo

Senior Product Associate, Digital Payments

JPMorgan Chase & Co.

New York, New York, USA

Full-time

The Payments organization is a motivated, forward-thinking team comprised of high talent product managers with a singular focus of delivering innovative payment services via the most important platforms of today and tomorrow. We seek to transform customer experiences, simplify the ways we do business, and aim for product excellence. We value controls, simplicity, and consistency in the capabilities and features we deliver. As a Senior Product Associate on the Payments organization, you will have

Learning Management System (LMS) Support Administrator (IT Senior Associate 3)

CUNY Central Office

New York, New York, USA

Full-time

Job Title: Learning Management System (LMS) Support Administrator (IT Senior Associate 3) The City University of New Yorks (CUNY) Office of Computing and Information Services (CIS) is seeking a Learning Management System (LMS) Support Administrator who possesses solid expertise in D2Ls Brightspace. Reporting to the Academic Collaboration Technology Applications Support Manager, they will be responsible for providing high-quality support to the University end user by managing the Learning Manage