Director Of Regulatory Affairs Jobs in the United States

Larimar Therapeutics

Philadelphia, PA

Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.

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.

Clinical Dynamix, Inc.

Watertown, MA

The Associate Director or Director of Regulatory Affairs will be a key member of the STAT6 Regulatory team working in partnership with the Global Program Regulatory lead to develop and execute on innovative and creative global regulatory strategies. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Company’s I/I portfolio of targeted protein degraders.

Joulé

$195500 - $245600

Denver, CO

A well-established and growth-oriented medical device organization is seeking a strategic regulatory leader to guide global regulatory affairs and labeling strategy across a diverse product portfolio. Required Experience:10+ years of progressive regulatory affairs experience within medical devices (combination product experience strongly preferred).

Clinical Dynamix, Inc.

San Diego, CA

Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.

Ironwood Pharmaceuticals

Boston, MA

Coordinate, review, and be accountable for the quality and timeliness of global CMC regulatory submissions and lifecycle filings, including original INDs, CMC amendments, IMPD amendments, annual reports, meeting requests, briefing packages, marketing applications, and post-approval changes. Lead preparation of high-quality CMC briefing packages and regulatory narratives for health authority meetings, including definition of regulatory positions, risk mitigation strategies, and alignment of supporting data; participate in or lead agency interactions as a key spokesperson.

ECLARO

$77.58 - $82.28

Lawrence Township, NJ

Responsibilities:Take on assigned projects to help with development and execution of functionally integrated and aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape. In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication.

Waters Corporation

San Diego, CA

Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites. • Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals.

Daiichi Sankyo, Inc.

Bernards, NJ

CDx RA Strategy: Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trials. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.

Agios Pharmaceuticals

$183549 - $275324

Anywhere, NY

The current base salary range for this position is expected to be between $183,549 – $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. As a key cross-functional partner, the Medical Director collaborates closely with Commercial, Clinical Development, Regulatory, and Market Access teams, among others, to shape brand and portfolio strategy, integrating real-world evidence and external expert perspectives.

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.

US Tech Solutions, Inc.

$160 - $170

North Chicago, IL

The Associate Director provides medical and scientific strategic and operational input into core Medical Affairs activities such as health care professional interactions, generation of clinical and scientific data (enhancing therapeutic benefit and value), and educational initiatives. Provides scientific and strategic input for external scientific communications and externally facing materials representative of the current patient needs and aligned with therapeutic area strategies (e.g.

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.

Daiichi Sankyo, Inc.

Washington, DC

Engage with trade and other membership organizations on priority issues, tracking developments and working to shape industry’s broader positioning to reflect Daiichi Sankyo’s business needs. Identify risks and opportunities and develop strategy for engagement on Daiichi Sankyo’s priority issues, collaborating with internal subject matter experts and aligning with leadership and Government Affairs & Public Policy team.

CSL Behring

King of Prussia, PA

You are a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as: Regulatory leaders who leverage regional regulatory experience / expertise to influence and actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’, effective inputs into risk assessment and decision making.

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.

Jobot

$200000 - $230000

South San Francisco, 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. 2. Leading the quality team in the execution of quality assurance activities, including inspection, testing, and auditing of our products to ensure they meet all required specifications.

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).

Larimar Therapeutics

Philadelphia, PA

The role partners closely with Drug Product Manufacturing, Clinical Supply Chain, Commercial (Marketing, Market Access, and Sales), Quality Assurance, Finance, and Medical Affairs to deliver a seamless patient experience that prevents missed doses and supports successful commercialization. The Associate Director/Director of Commercial Supply Chain is responsible for the end-to-end design, launch readiness, and ongoing execution of the commercial supply chain supporting a recombinant fusion protein therapy for the treatment of Friedreich’s ataxia.

Tacoma Community College

$105000

Tacoma WA 98466, WA, WA

Areas of responsibility include the oversight of Learning Technology Support operations including supervision of the Learning Technology Support Manager, oversight of the Instructional Design and Media Services teams, new educational technology initiatives, open education coordination, faculty development around teaching and learning with technology, and strategic leadership for instructional accessibility and inclusive technology integration. Moreover, TCC stands in solidarity with Black Lives Matter and the Black community by further strengthening collaboration with the Black Student Union as well as community entities such as the Tacoma-Pierce County Black Collective, the Tacoma Urban League, and local black-owned businesses.

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 .

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.

Microsoft

$160700 - $284400

San Francisco, CA

Bachelors Degree in Public Policy, Public Administration, Political Science, Business Administration, Technology, Law, Liberal Arts, Engineering, or related field AND 15+ years work experience in government affairs, corporate affairs, public policy, government, or related areaOR equivalent experience. Bachelors Degree in Public Policy, Public Administration, Political Science, Business Administration, Technology, Law, Liberal Arts, Engineering, or related field AND 8+ years work experience in government affairs, corporate affairs, public policy, government, or related areaOR equivalent experience.

Agios Pharmaceuticals

$229562 - $344342

Atlanta, GA

The role oversees a high-impact team and partners cross-functionally and externally to drive an integrated publications and scientific communications strategy, translating complex data into compelling evidence that supports clinical adoption, informs healthcare decision-making, and differentiates the company’s portfolio globally. Agios Pharmaceuticals is searching for a dynamic Senior Director, Global Scientific Communications and Publications expert to join our Global Medical Affairs team and lead a high-functioning communications/publications/congress team.

Discover Financial Services

$269600 - $307700

Richmond, VA

Credit Risk: Support LOB teams in driving step-change improvements in credit performance by connecting drivers of future consumer credit trends to a deep understanding of community trends and conditions, to inform risk models, and test hypotheses using rigorous monitoring and analysis. This team works in close collaboration with other teams in Community Impact and Investment (CI&I), Community Finance, Corporate Communications, Public Affairs, and Intelligence as well as project partnerships with teams in Retail, BC&P, Auto, Card, and Commercial.

Circle

$235000 - $290000

Atlanta, GA

Circle’s platform includes the world’s largest regulated stablecoin network anchored by USDC, Circle Payments Network for global money movement, and Arc, an enterprise-grade blockchain designed to become the Economic OS for the internet. This role sits at the center of Circle’s engagement with the largest, most complex financial institutions in the world and is critical to advancing USDC’s role in regulated payments, liquidity, treasury, and emerging on-chain financial infrastructure.

Agios Pharmaceuticals

$183549 - $275324

Boston, MA

The Director will reside within Medical Safety & Risk Management (MSRM) and work closely with Regulatory Affairs, Medical Affairs, Market Access, Commercial, Supply Chain, and Legal teams, as well as external vendors, to deliver high-quality REMS programs that meet FDA requirements and support product success. The current base salary range for this position is expected to be between $183,549 – $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.

CSL Behring

King of Prussia, PA

Interprets analysis results and ensures reporting accuracy in study reports and regulatory documents, abstracts, posters, oral presentations, manuscripts and written reports to effectively communicate results of clinical programs and studies.•May serve as the point of contact for one or more PSTs within the TA.•Lead or provide oversight to the analysis delivery and quantitative evaluation of clinical trials, and integrated analysis. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

Xenter

Draper, UT

This role is both strategic and operational—responsible for developing regulatory pathways for innovative products, building scalable regulatory infrastructure, and partnering cross-functionally to drive successful product approvals and launches. Xenter is revolutionizing medicine by developing and launching smart/wireless guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that collects and houses real-time Physical Intelligence medical data.

Caldera Medical

$150000 - $176000

Westlake Village, CA

The Director of Regulatory Affairs will lead global regulatory strategy, manage submissions, obtain necessary licenses and approvals, and ensure compliance with U.S. and international regulations including FDA, EU MDR/MDD, MDSAP, NMPA, TGA, and other global regulatory bodies. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal.

CEDENT

undefined, MD

Summary:The Director of Regulatory Affairs is responsible for overseeing regulatory compliance initiatives to support patient safety and quality, ensuring adherence to Federal, State, and local regulations. Coordinate virtual and onsite surveys by external regulatory and accreditation agencies, as well as mock surveys by consultants or internal teams.

Columbia Greene Community College

Hudson, NY

Inizio Engage

Bridgewater, NJ

Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. This highly visible role will lead the execution of aligned marketing tactics across Healthcare Professional (HCP) and Consumer/Patient audiences, spanning personal promotion, non-personal promotion, digital media, communications, public relations, and additional strategic channels.

Baylor Scott & White Health

Dallas, TX

The BSWH system includes 47 hospitals, more than 900 access points, over 6,600 physicians and 43,500 employees, plus a state certified Health Maintenance Organization, the Scott and White Health Plan (Health Plan), and Baylor Quality Health Care Alliance LLC (BSWQA) – a high performing network of clinical providers and facilities focused on improving quality, managing the health of patient populations, and reducing the overall cost of care. BSWH includes a robust spectrum of owned, operated, ventured and affiliated hospitals; satellite outpatient clinics; free standing ambulatory surgery centers; free standing emergency medical centers; free standing imaging centers; numerous retail pharmacies; and geographically dispersed physician’s clinics in the North Texas and Central Texas regions.

Chelan County PUD

$176640 - $220800

Wenatchee, WA

Chelan Public Utility District is seeking an experienced Director of Communications & Public Affairs to lead how we inform, engage, and build trust with our customer-owners, communities, and public partners. The Director serves as a key advisor to the Board of Commissioners and executive leadership, ensuring clear, transparent, and consistent communication in support of Chelan PUD’s public mission.

Discover Financial Services

$209500 - $239100

McLean, VA

This will include overseeing the horizontal leadership of Syndicator relationships (management of Upper tier funds, including agreement negotiation and adherence, coordination of syndicator survey, syndicator guide, communication, capital calls, benefit schedule coordination). About the Team: Global External Affairs (“GEA”) works with many external and internal stakeholders to envision and create a world of greater socioeconomic opportunity through advocating for an inclusive society, building thriving communities, and creating financial tools that enrich lives.

Coyote Technical & Executive Sourcing

Fairfield, CT

Minimum Experience: 15 years of Quality Assurance, Quality Engineering, and Regulatory experience in a FDA regulated environment, preferably Medical Devices, Gastrointestinal. Hands-on Director who is responsible for the Regulatory Affairs and Quality Assurance strategy, policies, and procedures to ensure we follow all domestic and international guidelines and regulations.

Tacoma Community College

$105000 - $115000

Tacoma WA 98466, WA, WA

A BSN degree from a nursing education program accredited by a national nursing education accrediting body recognized by the United States department of Education and a graduate degree, OR a graduate degree from a nursing education program accredited by a national nursing education accrediting body recognized by the United States Department of Education. While the primary focus of the role is the Nursing program, the Associate Dean also supports the broader Healthcare Pathway by participating in division-level planning, contributing to cross-program initiatives, and ensuring alignment with institutional priorities and workforce needs.

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.

Daiichi Sankyo, Inc.

Bernards, NJ

Global Biostatistics & Data Management (BDM) Strategy to Improve Drug Development: Leads the implementation of the BDM vision and strategy, and identifies technology and infrastructure needs and leads the development and improvement of needed technology and infrastructure for the function to improve harmonization and efficiency which leads to cost savings and productivity. Define the vision and mission of the group; manage statistical programming resources to support project needs; be accountable for the quality of the statistical programming deliverables; be responsible for recruiting, retaining, developing, and managing employees; be responsible for talent development including providing guidance for career growth and providing development opportunities for the direct reports.

MastarRec

Bleiblerville, TX

Leads engagement with federal and state regulators, manages licensing requirements, and oversees regulatory change management. • Multi-jurisdiction financial services exposure.

Daiichi Sankyo, Inc.

Bernards, NJ

Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.

Swire Pacific Holdings Inc.

$152264 - $199846

Bellevue, WA

The Director of Public Relations & Government Affairs serves as a regional leader for Swire Coca-Cola, USA, overseeing a multi-state territory to support business operations by enhancing the company's visibility, cultivating and maintaining key relationships, and strengthening government affairs capabilities. As a critical member of the Public Relations and Government Affairs team, this role reports to the Senior Director of Public Relations and Government Affairs and is the primary media spokesperson and represents the company's interests at local, state, and federal levels, engaging with both public and private sector partners.

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.

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.

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.

BaRupOn LLC

Irvine, CA

BaRupOn LLC is seeking a highly experienced Director of Licensing & Regulatory Affairs to lead all regulatory strategy, licensing execution, and compliance activities for its Small Modular Reactor (SMR) and Micro Modular Reactor (MMR) programs in the United States. The ideal candidate brings deep, direct NRC engagement experience, a thorough command of U.S. nuclear regulatory frameworks, and the leadership ability to build and manage a high-performing regulatory team in a fast-moving, mission-driven environment.

Boehringer Ingelheim

$170000 - $269000

Ridgefield, CT

If you want to apply for the position in Germany , please use this link: Senior Regulatory Affairs Manager CMC for NBE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NBE-Germ/1271415301/) and/or Senior Regulatory Affairs Manager CMC for NCE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NCE-Germ/1271422201/). + Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.

ChromoLogic

$130000 - $170000

Monrovia, CA

Covisus Inc. (www.covisus.com) is a VC-funded spin-off from ChromoLogic that has developed an award-winning and industry-leading technology for tagless tracking of assets based on its vTag® technology. Develop and implement quality assurance strategies and regulatory compliance programs (FDA 510(k), PMA, IDE, drug approval, IND, pre-submission).