Regulatory Affairs Manager Jobs in the United States
TalentBurst, Inc.
$70 - $73
San Rafael, CA
Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings. The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the Client's regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
Clinical Dynamix, Inc.
Bridgewater, NJ
Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required. • Liaise with regulatory authorities as needed pertaining to drug development and product lifecycle management.
Dentsply Sirona
Milford, DE
Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Joulé
$100000 - $130000
Jersey City, NJ
We’re seeking a hands-on, proactive QA/RA Manager who thrives in a fast-paced, small-company environment and is ready to take ownership of Quality, Regulatory, and QC Laboratory oversight, including QC microbiology testing, LAL endotoxin testing, and overall QC compliance activities. This role is ideal for a driven leader who wants full visibility, autonomy, and impact across manufacturing, regulatory strategy, audits, and day-to-day quality operations.
Iconma
Marlborough, MA
Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables. Requirements:Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion (7-10 years experience).
Clinical Dynamix, Inc.
Cambridge, MA
Regulatory Affairs recommends development phase-appropriate strategies and tasks to guide development in compliance with regulation and regulatory guidance to maximize efficient and successfully leading to regulatory approval for the company’s off-the-shelf stem cell technology. The Vice President of Regulatory Affairs will be a member of the Leadership Team and work closely with the various members of Executive Leadership, Program Management, Technical Operations, and Nonclinical Development.
Medline Industries - Transportation & Operations
Bloomington, MN
Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
TalentBurst, Inc.
$70 - $75
Cambridge, MA
Exposure to Starting Point templates, SharePoint, EndNote, and Toolbox Pharma preferred Alignment with *** Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence. Bachelor's degree in a relevant scientific/technical field or equivalent experience 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing within a regulatory environment.
Genesis10
Foster City, CA
This role serves as a strategic partner and operational leader within the Medical Affairs organization of a major pharmaceutical company, supporting US field initiatives. The position partners with cross-functional teams to drive operational excellence, strategic planning, and project execution to support the US Field Medical Team.
FTI Consulting
New York, NY
Your responsibilities will include developing and executing integrated communications strategies that support our clients policy objectives, drafting compelling materials such as advocacy plans, strategy and policy memos, press releases, and briefing documents, and preparing clients for high-stakes engagements with media, policymakers, and a broad range of internal and external stakeholder audiences. Over the last 40 years, FTI Consulting experts have served as the trusted advisor to Fortune 500 companies and the world’s leading law and private equity firms when they are facing their greatest opportunities and challenges.
Flagstar Bank
$84878 - $112463
New York, 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.
Daiichi Sankyo, Inc.
Bernards, NJ
It is responsible for ensuring reliable production support across critical commercial data domains (Sales, Omnichannel, Patient, Marketing, Medical Affairs).This includes managing incidents and inquiries, driving root cause analysis, and restoring services quickly to minimize disruption and protect business outcomes. Additionally, the role manages cloud enterprise platforms – such as Informatica IICS, Veeva Network, SAS, and Power BI – to ensure their availability, correct configuration, operational stability, and ability to scale securely in line with business needs.
Atrium Staffing
$65000 - $80000
Freehold, NJ
Responsibilities of the Food Labeling & Regulatory Coordinator (Supplements): Review and approve product labels, supplement facts, packaging components, and marketing claims to ensure compliance with 21 CFR Part 111, NSF 455-2, and FDA labeling regulations. Required Experience/Skills for the Food Labeling & Regulatory Coordinator (Supplements): Minimum 2 years in a regulatory, labeling, or certifications-focused role within the food, beverage, or supplement industry.
Canfield Scientific, Inc
Parsippany, NJ
The ideal candidate for our Clinical Outcome Technology Project Manager position has great communication skills, is self-motivated and passionate about their work, has a strong desire to grow professionally, possesses an eagerness to be part of a dynamic group of focused and creative individuals and has excellent time management skills. Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation.
Flagstar Bank
$84878 - $112463
New York, 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.
Artech LLC
Mountain View, CA
This department plays a crucial role in maintaining product and process quality, supporting commercial production for all products including laser consoles, delivery devices, and accessories. Manage supplier quality assurance activities, including supporting new supplier approval and monitoring performance of existing suppliers.
Joulé
Plainsboro Township, New Jersey
This role plays a critical part in demonstrating unmet medical needs, product differentiation, and value through rigorous analysis of real-world data (RWD).As part of a collaborative RWE analytics team, you will work closely with cross-functional stakeholders to generate, analyze, visualize, and communicate evidence that informs clinical development, regulatory strategy, safety evaluation, and market access decisions. Ideal for a hands-on statistical programmer with a passion for healthcare innovation, this contract role offers the chance to operate in a fast-moving, collaborative environment where your expertise directly contributes to advancing research and improving patient outcomes.
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 Manager, Manufacturing, Cartridge Line 1st Shift will play a part in the facility start-up, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site.
First Horizon Bank
Roswell, GA
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
Durham, 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.
LUV Car Wash
$55000 - $65000
Pooler, GA
The General Manager (GM) is responsible for all site operations including recruiting of staff, site safety, facilities management, customer service, driving sales, site compliance and the development of the car wash team. Partner with Facilities to ensure all equipment is properly maintained, safely operated and maintenance requests are fulfilled in a timely manner to minimize site downtime.
SOFIE
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.
BESTMSLs
Orlando, FL
The Medical Science Liaison (MSL) will serve as the field-based scientific expert whose mission is to foster collaborative relationships with opinion leaders focused on a rare hematologic disorder and to facilitate the exchange of unbiased scientific information between the medical community and the company. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear.
Chemtall/ SNF Holding
null, 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. Strong working knowledge of ISO 9001, ISO 14001, and RC14001, with demonstrated experience implementing and sustaining management systems; Certified Lead Auditor strongly preferred.
Fast Pace Health
Elizabeth City, 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
Elizabeth City, 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.
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.
Hawaiian Electric Industries
Honolulu, HI
Manages the end-to-end process including complex regulatory approvals, land/Right-of-Way acquisition, public relations management, or cross-functional/multi-level (internal) management from conceptualization/ inception through budgeting, design, approval, procurement, construction, placement in operation, and project closing. o Works with and through community groups, neighborhood boards, government agencies, the media, other utilities and private companies, the City Council, the State Legislature, and the PUC to disseminate information, address concerns, obtain permits and approvals, and resolve project-related problems.
DLA Piper LLP (US)
$34.08 - $50.96
Seattle, WA
As a member of the Business Development's Pitch & Proposal team, the Pursuits & Directories Sr Coordinator - Regulatory & Government Affairs, has a primary responsibility for assisting the Firm win new business through the development of compliant, on-time, best-in-class and client-centric formal RFP responses and pitch responses. This position can sit in our Atlanta, Austin, Baltimore, Boston, Tampa, Chicago, Dallas, Houston, Los Angeles, Miami, Minneapolis, New York, Northern Virginia, Philadelphia, Phoenix, Raleigh, San Diego, Seattle, Short Hills, Washington D.C., or Wilmington office and offers a hybrid work schedule.
Jobot
$130000 - $160000
Atlanta, GA
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Working knowledge of short and long-term budgeting and forecasting, rolling budgets, and product-line profitability analysis.
Flagstar Bank
Troy, MI
Key areas of focus include the development of the annual Regulatory Compliance Training Plan, development of BU role-based training, development of ad hoc training, creation and delivery of Lunch and Learn presentations designed to enhance BU understanding of applicable LRR, ensuring accuracy and thoroughness of training impacting LRR developed by the BUs, and conducting due diligence training reviews of the Banks third party vendors. The Compliance Training Manager is responsible for developing and maintaining a Compliance Management Program (CMP) for the Bank that reasonably ensures compliance with applicable laws, rules, and regulations (LRR), addresses associated risks of harm to consumers and customers and integrates Regulatory Compliance into the day-to-day responsibilities of its management, employees, and contractors.
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.
Daiichi Sankyo, Inc.
Bernards, NJ
The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Daiichi Sankyo, Inc.
Bernards, NJ
Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities • Demonstrated ability to lead and influence others internally and externally • Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. Responsible for the development of the USOMA strategy and medical objectives for the assigned compound and leads development and execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Participates in Global Medical Affairs committees as requested.
Daiichi Sankyo, Inc.
Bernards, NJ
Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.
VistaApex Solutions
Racine, WI
The Regulatory Affairs Manager provides regulatory leadership and support across the organization, ensuring compliance with Quality System Regulation (21 CFR 820), the European Medical Device Regulation (MDR), UKCA requirements, and ISO 13485:2016. VistaApex Solutions is a purpose-driven, clinician-focused healthcare platform bringing together leading dental brands, including Vista Apex, PerioProtect, and PerioSciences.
Flagstar Bank
$158999.25 - $267650
New York, NY
The Associate General Counsel acts as the primary resource for the business regarding review and management of complex legal affairs relating to assigned legal discipline or business lines, Commercial Lending, Consumer Compliance, Mortgage Banking, Contracts, Real Estate, Corporate Governance, Litigation, Private Banking, Employment Law. Has direct experience working for a practice group at a large bank and/or large law firm providing legal support to financial institutions and be familiar with current market practice and trends, applicable banking regulations and model forms and guidance issued by relevant trade associations.
Vaco LLC
$45 - $55
New York, NY
Partner with CLAO on management of Board and related committees; Review and/or prepare for filing various financial reporting documents, such as the Form 990 and state registration forms, filings relating to lobbying compliance, filings relating to governmental pre-qualifications and filings due to watchdog agencies, such as the Better Business Bureau; Develop and deliver trainings and workshops for staff; Monitor and advise the CLAO and others on legislative developments related to nonprofit organizations, including human resources and benefits-related legislation; and. This will include reviewing, drafting, and negotiating contracts and other documents, such as: sponsorship agreements, grant agreements, non-disclosure agreements, consulting agreements, and licenses and releases, and advise senior management on related issues; Assist CLAO in ensuring organizational compliance with applicable laws and regulations, such as lobbying, regulatory and public policy matters, and laws relating to charitable solicitations in New York State and nationally; Advise on risk management practice, liability, and insurance matters; Prepare materials for Board and committee meetings.
Fast Pace Health
Midway, 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
Brazil, IN
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
Greencastle, IN
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
Greenfield, IN
Posting Title: FLOAT - 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.
T-Mobile USA, Inc
Bellevue, WA
Conduct and document vendor compliance assessments and ongoing monitoring in collaboration with Enterprise Risk & Third Party Risk Management, Procurement, Privacy, Cybersecurity, and Enterprise Controls Testing & Monitoring for adherence to regulatory, legal, and contractual requirements. Minimum 5 years of experience in financial services compliance, regulatory risk management, or third-party oversight (experience with fintechs or bank partnerships strongly preferred).
Fast Pace Health
Muldraugh, 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
Pinson, AL
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
Angola, 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. 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
Cub Run, 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
Gibson, 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.