Regulatory Affairs Manager Jobs in the United States
Joulé
$105000 - $110000
Plainsboro Township, NJ
We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist (Contractor) to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. Labeling Tools:Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc.) as well as coordinating technical support needs with internal IT groups.
Daiichi Sankyo, Inc.
Bernards, NJ
Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues. Serve as a key liaison to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement.
ProKatchers
Columbus, OH
5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Quality, R&D, Project Management, Procurement or Operations function and good knowledge of food GxP and nutritional regulations. Bachelor’s degree in a relevant discipline/or equivalent work experience is required (Business Administration, Chemistry, Microbiology, Food Science, Engineering).
Aquestive Therapeutics
Warren, NJ
This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.
Daiichi Sankyo, Inc.
Bernards, NJ
The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals. Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
Flagstar Bank
$84878 - $112463
Rockville Centre, NY
Reviews various reports including check fraud, significant activity, significant change, large deposit, detailed transaction report and month-end reports; investigate & approve when needed. Develops and expands existing relationships including sales efforts; engages key Product Partners as appropriate in delivering the full breadth of the bank to satisfy clients needs.
Constellation Energy
$152100 - $169000
Warrenville, IL
Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies.
First Horizon Bank
Shreveport, LA
Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
First Horizon Bank
Asheboro, NC
Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
VNS Health
$85000 - $106300
New York, NY
Minimum two years of clinical assessment, homecare or hospital experience requiredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrated strong relationship management skills, including a high degree of psychological sophistication and non-aggressive assertiveness requiredDemonstrated successful conflict management skills and negotiation of “win-win” solutions requiredWorking knowledge of Microsoft Excel, Power-Point, and Word requiredKnowledge of Medicaid and/or Medicare regulations requiredWorking Knowledge of UAS-NY preferred . Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond.
SOFIE
$90000 - $100000
Totowa, NJ
The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
Fast Pace Health
Mermentau, LA
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Leesville, LA
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Constellation Brands
$88700 - $135900
Rochester, NY
An employee’s pay position within the salary range will be based on several factors including, but not limited to, the prevailing minimum wage for the location, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, shift, travel requirements, sales or revenue-based metrics, any collective bargaining agreements, and business or organizational needs. In addition, this position will assist the Director, Corporate EHS with merger and acquisition due diligence activities, implementation and sustainment of the global EHS management system, global EHS risk assessment, EHS metrics reporting and on-location technical support.
Medline Industries - Transportation & Operations
Chicago, IL
Knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices, or willingness to learn through training and independent research. - Train and mentor new employees, divisional QA's and product managers on regulatory product structure, regulatory labeling requirements, and Medline labeling procedure(s).
DLA Piper LLP (US)
$168478 - $272949
Seattle, WA
While the specific job requirements of a DLA Piper position may vary depending upon scope of the job and area of specialty, there are certain universal requirements that are expected of all DLA Piper employees, which include but are not limited to: Effectively communicate, verbally and in writing, with clients, lawyers, business professionals, and third parties. Prior substantive legal experience in one or more of the practice's subgroups, including Data Protection, Privacy & Security; Environmental; FDA Regulatory; Financial Regulatory & Technology; Government Affairs & Public Policy; Government Contracts; Healthcare Regulatory; National Security & Global Trade; Telecom; and Transportation Regulatory.
Pyramid Consulting, Inc
$50 - $55
Foster City, CA
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Immediate need for a talented Medical Information Manager / MLR Review Specialist (Veeva, Oncology, Pharma) .
Medline Industries - Transportation & Operations
Northfield, IL
Some of the activities for the manager will include negotiating supplier price reductions and analyzing geo-political risks, resolving price and cost disagreements with vendors, coordination with supply chain, quality, and overseas offices, and overseeing vendor relationships. Manage an entire divisional portfolio of managed categories leveraging sourcing experience to drive continuous improvement across all Category Managers with the goal to contain costs, drive improved raw material consumption, and other-cost down initiatives.
Company Confidential
$75000 - $95000
RENTON, WA
We are seeking a Compliance & Legal Affairs Manager to oversee regulatory compliance, contract review, and risk management across all areas of our operations. Identify legal and business risks; propose practical mitigation strategies.
VNS Health
$85000 - $106300
New York, NY
Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond. • Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan.
Snf Holding Company
Riceboro, GA
While the Integrated Management System (IMS) is owned by the Responsible Care® organization, this role serves as a critical Quality partner, responsible for quality investigations, customer complaints, CAPA effectiveness, performance metrics, and IMS audit execution. The Senior Quality Manager provides senior-level leadership and hands-on support to Quality teams across one large manufacturing site and multiple smaller sites.
OneMain Financial
$80000 - $96000
Baltimore, MD
The leader will be responsible to collaborate with business, operations, product, and technology partners to deliver the engineering, systems integration and process improvement needs for all aspects of the Regulatory & Compliance support systems, inclusive of the day-to-day running of the engineering teams. Excellent verbal and written communication skills required for composing and delivering technical presentations or other forms of documentation to various level of technical and non-technical management.
Grid United
Houston, TX
Established in 2021 by proven industry leaders, Grid United is developing utility-scale electric multi-state transmission projects that will provide long-term economic benefits to communities across the country, provide Americans with improved grid resiliency for our homes and businesses, and cost savings for electricity consumers. Grid United is a mission-driven company aiming to solve the largest barrier to a more reliable, resilient and affordable grid by developing new long haul electric transmission lines in the United States.
BIO RAD LABORATORIES - 390
$116100 - $159600
Seattle, WA
This role represents Clinical Affairs collaborates cross-functionally with Regulatory Affairs, R&D, Quality, Marketing, and external partners to deliver high-quality clinical data and evidence supporting product registration and commercialization of Bio-Rad diagnostic products. Work Experience: 5 years' (3 years' with advanced degree) experience in clinical research with at least 3 years of clinical trials execution role, preferably in an IVD company; and 1 year of people management experience.
Cerapedics Inc
$130000 - $140000
Westminster, CO
Develop, author, assemble, publish and submit IDE Annual Reports, Post-Approval Study Annual Reports, and PMA Annual Reports, ensuring timely submission in accordance with FDA Approvals. As a Regulatory Affairs Manager working on the Regulatory Affairs team, you will be empowered through meaningful work and career development to coordinate closely with cross-functional partners and others on the development, submission, and prosecution of Regulatory filings.
Fast Pace Health
Durham, NC
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Leesville, LA
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Caneyville, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Fast Pace Health
Fayetteville, TN
Posting Title: Family Nurse Practitioner/Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Fast Pace Health
Oakland, MS
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Richland, MS
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Morgan City, LA
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner - FLOAT Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Payneville, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Fort Knox, KY
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. Posting Title: Family Nurse Practitioner Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.
Fast Pace Health
Salem, IN
They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere. The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers.
Werfen
$95000 - $170000
San Diego, California
Teamwork: Coordinate with department leadership and other cross-functional areas including R&D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, product changes, international product registrations, review of Advertising & Promotional Materials, etc. On-Market Support (Sustaining): Provide leadership, guidance and assistance to the Regulatory Affairs team in the regulatory impact assessments of changes on existing Market Authorizations that include but are not limited to design changes, changes to product composition, manufacturing processes, and the labeling of products.
Larimar Therapeutics
Philadelphia, PA
The successful candidate will have a deep understanding of business and market dynamics, transactions and partnerships, a track record of developing and executing successful corporate strategies, robust understanding of finance, and the ability to work collaboratively with cross-functional teams. Foster collaborative and supportive cross-functional working relationships, including engaging the senior leadership team in the development and prioritization of long-term strategies and acting as a thought partner with the business to make effective and timely decisions .
BaRupOn LLC
$105000 - $140000
Liberty, TX
BaRupOn LLC is a multi-sector infrastructure and energy company with a bold mission: to deliver transformational projects that power communities, advance healthcare, and drive sustainable development across the globe. With operations spanning solar and gas-powered energy systems, complex civil construction, and medical and healthcare innovation, BaRupOn operates at the intersection of resilience, scale, and impact.
CEDENT
Santa Clarita, CA
The Regulatory & Quality Affairs Manager ensures all facilities and or business entities maintain full compliance with all applicable state & federal regulatory requirements and guidelines for the marketing, sales, warehousing and distribution of the company’s products in their respective target markets. Ensure that known compliance risks (via internal/external audits, changes in regulations, changes in business structure/products) are mitigated via quality/compliance plans.
Changent
$88000 - $100000
Denver, CO
The position focuses on federal program implementation and regulatory analysis tied to initiatives, such as the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program and the Family First Prevention Services Act. The Regulatory Affairs Manager advances the work of Changent to strengthen the systems and partnerships that support maternal, infant, and early childhood health.
Civica Rx
Petersburg, VA
CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. The Supervisor, Manufacturing Support (Evening Shift 6:00 PM - 6:30 AM), will play a role in facility start-up and commercialization, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site.
Civica Rx
Petersburg, VA
CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. The Supervisor, Manufacturing Support (Day Shift 6:00 AM - 6:30 PM), will play a role in facility start-up and commercialization, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site.
Werfen
Bedford, Massachusetts
Lead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.