Regulatory Affairs Manager Jobs in the United States
Flagstar Bank
Hicksville, NY
Works closely with Regulatory Affairs Managers to ensure business unit account remediation projects meet regulatory expectations, have effective project plans, and provide regular reporting to Bank executives and the Board. Minimum experience required: 10+ Years of banking risk management and bank regulatory experience with focus on project management working on regulatory matters and remediation.
Abbott Laboratories
$112000 - $224000 undefined
Alameda, CA
You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
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.
Abbott Laboratories
$112000 - $224000 undefined
Alameda, CA
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions.
Jazz Pharmaceuticals
$72.92 - $87.5 HOUR
Philadelphia, PA
The Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals’ Global Medical and Promotional Regulatory Affairs group and will be assuming a leadership role in the promotional materials review; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
Abbott Laboratories
$146700 - $293300 undefined
Livermore, CA
Directly manages team responsible for following: payor contract negotiation, payor contract implementation, payor contract monitoring, Medicare/Medicaid enrollment, state licensing, and Joint Commission accreditation. Regulatory compliance and policy management in one (or multiple) of the following fields: DME, IDTF, hospital administration, Medicare, Medicaid, commercial payors.
Dynex Technologies
Chantilly, VA
About Dynex: Founded 70 years ago, DYNEX® TECHNOLOGIES, Inc., is a leading designer and manufacturer of fully automated ELISA microplate workstations, laboratory instruments and associated consumables and accessories, seamlessly integrating advanced detection with fully automated sample handling. All dedicated to perpetual innovation in product design and new application frontiers to deliver cutting-edge microplate processing systems that meet the rigorous demands of the most challenging applications and ultimately improve health outcomes and enhance life.
Medline Industries - Transportation & Operations
Northfield, IL
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.
Daiichi Sankyo, Inc.
Bernards, NJ
In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
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.
Adtalem Global Education
$137846.78 - $241870.9 undefined
Chicago, IL
In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements in the areas of academics, career services, enrollment management, state and provincial licensing, student finance, and student services. Leading multiple teams, the Senior Director drives compliant implementation and maintenance of applicable higher education requirements in Adtalem operations and uses a consultative mindset to provide regulatory guidance to support institutional strategy.
Abbott Laboratories
$112000 - $224000 undefined
Alameda, CA
As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - An affordable and convenient path to getting a bachelor’s degree.
Sanofi
MORRISTOWN, NJ
Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
USAA
$127310 - $229160 YEAR
San Antonio, TX
Advises business leadership on communications, reputation management, corporate impact, and stakeholder engagement strategies, ensuring Corporate Affairs enables enterprise strategy, drives growth, and mitigates risk. You will also be responsible for developing and executing corporate impact strategies that advance enterprise priorities, protect and elevate the company’s reputation, and connect employees and stakeholders to USAA’s mission.
Daiichi Sankyo, Inc.
Bernards, NJ
Ensure CAPA effectiveness checks are conducted and provide updates on quality status to business functions in a timely manner through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Demonstrated experience and proven track record of successfully leading global projects with high impact with ability to lead and project-manage cross-functionally and globally with business stakeholders is highly-preferred.
Jobot
$90000 - $120000 YEAR
Los Angeles, CA
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. They’re looking for a tech-savvy and detail-oriented Quality Systems & Regulatory Manager to lead food safety systems, labeling accuracy, customer compliance documentation, and cross-functional audit readiness.
See's Candies
$75000 - $90000 YEAR
South San Francisco, CA
The Regulatory Affairs & Technical Services Specialist is responsible for developing and maintaining appropriate records to meet corporate and government requirements, ensuring the accuracy of product labeling, and offering regulatory expertise on emerging federal and state laws. Responsible for developing finished product nutrition labels and technical information using Genesis Foods software, including but not limited to: ingredient statement, allergen statement, nutrition facts panel, validation of nutrition claims.
Abbott Laboratories
$97300 - $194700 undefined
MapleGrove, MN
As an individual contributor, the function of a Compliance Manager is to combine the knowledge of Regulatory, Quality and Compliance to manage implementation of global emerging regulations and improve procedural compliance in response to Abbott Regulatory teams’ requests working closely with the international regulatory affiliates, the medical device business unit RA teams and cross functional groups. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.