Director Of Regulatory Affairs Jobs in the United States

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.

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.

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.

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.

OhioHealth

Marion, OH

Reporting to the Vice President of Acute Care Services, the Vice President Clinical Affairs (VPCA), directs and coordinates the clinical affair activities of OhioHealth, for specifically assigned care sites. Drives program growth, quality outcomes, patient attribution, recruitment, acquisitions, service excellence, and fiscal targets by collaborating across OhioHealth, Clinical Enterprise, Population Health, and Acute Care operations in a matrixed environment.

Dentsply Sirona

Charlotte, NC

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.

Lundbeck

$200000 - $235000

Deerfield, IL

The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to ensure the successful development and approval of assigned drug and biological products for the United States (global products as well as US only products). Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings.

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).

Jazz Pharmaceuticals

$252000 - $378000

Palo Alto, CA

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. The Senior Director, Head of Clinical Statistical Programming leads the Statistical Programming Organization reporting into the VP of Data Science, Evidence and Value Generation and Global Medical and Scientific Affairs.

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.

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.

Sutter East Bay Medical Group

Oakland, CA

Regardless of area of special expertise, regular participation in clinical teaching in all sites: Morning report and Alta Bates Summit Medical Center teaching rounds, Resident and faculty didactic conferences, Faculty development. The Program Director (PD) directs all operations of the Sutter Health Internal Medicine Residency Program at Alta Bates Summit Medical Center and clinical patient care provided by residents and faculty.

Jazz Pharmaceuticals

$256000 - $384000

Philadelphia, PA

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. The role requires strong partnerships with Medical Affairs, Clinical Development, Commercial, Regulatory, and Market Access teams, as well as influential engagement with external experts in breast cancer and other relevant tumour types.

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 .

Microsoft

$160700 - $284400

New York, NY

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.

Circle

$235000 - $290000

Chicago, IL

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.

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.

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.

Columbia Greene Community College

Hudson, NY

Jazz Pharmaceuticals

$172000 - $258000

San Diego, CA

The AD partners closely with internal Market Access teams—including Payer Accounts, Field Access & Reimbursement, Patient Access Services, Wholesaler/Pharmacy Accounts, and LTC Account Teams to develop and execute franchise‑aligned strategies and tactics, ensuring each team is equipped with the tools, messaging, and resources needed to optimize customer engagement. Partner across Market Access functions—Market Access Marketing, Pricing/Contracting & Reimbursement, Channel Distribution & Trade Relations, Patient Access Services, Payer Field Teams, Payer Value & Outcomes, and Market Access Analytics & Insights—to support the execution of cohesive and integrated strategies.

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.

Jazz Pharmaceuticals

$348000 - $522000

Philadelphia, PA

This role oversees a portfolio of innovative therapeutic candidates and plays a critical role in shaping the early development pipeline, integrating translational science, biomarker strategy, and clinical execution to advance assets efficiently to proof‑of‑concept and late‑stage development. 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.

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.

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.

Jazz Pharmaceuticals

$196000 - $294000

Philadelphia, PA

Lead and drive the end‑to‑end Labeling Committee (LC) process, providing project management and strategic direction from the decision to update a CCDS or product information (including patient information labeling), through cross‑functional alignment and stakeholder notification, ensuring deliverables meet internal SOPs and global regulatory expectations. 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.

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.

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.

Jazz Pharmaceuticals

$232000 - $348000

Palo Alto, CA

Primary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.

U.S. Renal Care

Waterville, OH

Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.

U.S. Renal Care

Waterville, OH

Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.

MastarRec

Bleiblerville, TX

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

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.

Jazz Pharmaceuticals

$160000 - $240000

Tallahassee, FL

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. The Regional Marketing Manager will drive KOL engagement for a recently launched first in class HER2 targeted bispecific in biliary cancer (BTC) and with data expected in gastroesophageal adenocarcinoma (GEA).

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.

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.

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.

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.

Kymera Therapeutics

$160000 - $275000

Watertown, MA

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. 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 Kymera's I/I portfolio of targeted protein degraders.

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.

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.

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).

Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.

Septerna

$235000 - $260000

South San Francisco, CA

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.

U.S. Renal Care

Cyril, OK

Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.

Pyramid Consulting, Inc

$43 - $45

Atlanta, GA

Reviews treatment plans/plan of care with provider for requested services/procedures, inpatient admissions or continued stay, clarifying medical information with provider if needed. Collaborates with case management staff or physician to determine alternative setting at times and provide support to facilitate discharge to the most appropriate setting.