Director Of Regulatory Affairs Jobs in the United States

Joulé

$150 - $225

Florham Park, NJ

Support under supervision external scientific engagement for assigned assets, including KOL strategy, advisory activities, investigator-initiated research, and partnerships with external experts and advocacy groups. Provide support and scientific input into evidence generation activities, including Integrated Evidence Plans and lifecycle evidence planning, in partnership with Evidence Generation and Development teams.

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.

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.

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.

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.

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).

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).

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.

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.

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.

BESTMSLs

Los Angeles, CA

The individual engages with healthcare professionals (HCPs), key opinion leaders (KOLs), academic institutions, and other external stakeholders in a non-promotional, scientifically rigorous manner. A global biopharmaceutical organization is seeking an experienced Medical Science Liaison (MSL) at Associate Director level to support its US Respiratory portfolio.

University at Albany - State University of New York

Albany, NY

About University at Albany: Established in 1844 and designated a University Center of the State University of New York in 1962, the University at Albany's broad mission of excellence in undergraduate and graduate education, research, and public service engages a diverse student body of more than 17,000 students in nine schools and colleges across three campuses. The Director leads institution-wide efforts and NYSED-funded programs that prepare both pre-college and college students for success in STEM and licensed professions, working collaboratively across departments to support inclusive excellence.

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.

Diagnostica Stago, Inc.

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Bachelor's degree from four-year college or university required; Advanced degree preferred; Minimum 7 to 10 years experience in the diagnostics area and 5+ years of management experience. Establishes and maintains a strong collaboration with Corporate to ensure consistent reporting within the KPI process and consistency of processes and SOPs for the benefit of the group.

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.

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.

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.

Clinical Dynamix, Inc.

Watertown, MA

This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones.

MastarRec

NYC, NY

The Director of Regulatory Affairs leads external regulatory engagement, licensing strategy, and regulatory change management for a US FinTech. This role ensures the organisation remains ahead of regulatory developments and maintains strong, credible relationships with oversight bodies.

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.

Clinical Dynamix, Inc.

Watertown, MA

Prepare and review essential documents such as medical monitoring plans, statistical analysis plans (SAPs), informed consent forms, and clinical study reports, supporting regulatory submissions. Work within a matrix environment, collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, statistics, and other departments to drive clinical development programs forward.

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.

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.

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.

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.

Pangea Laboratory, LLC

$130000 - $160000

Tustin, CA

This role focuses primarily on clinical trials and submissions to enable regulatory authorization (IVDR and FDA) and market access for Bladder CARE, while also supporting emerging initiatives in NGS-based microbiome diagnostics. Actual compensation details will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

CEDENT

Cambridge, MA

Summary:Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing regulatory strategies from early development through late-stage clinical programs. Experience in key areas of regulatory affairs, including strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus.

Daiichi Sankyo, Inc.

Bernards, NJ

This individual will work cross functionally to integrate insights and key assumptions into forecast models and NPV (Net Product Value) calculations which inform decision to invest into pivotal clinical trials, decisions to file, decisions to upscale or downscale long-term manufacturing planning and other strategic decision for the pipeline products. Director of forecasting serves as a strategic partner to the senior leadership by assessing and presenting financial scenarios within the Oncology business unit and helps brand teams and stakeholders make informed strategic decisions through the clear development & articulation of scenarios under consideration.

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.

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.

LLoyd Staffing

Woodcliff Lake, NJ

Executive Director, Regulatory Affairs (Neurology) – Detailed SummaryLocation: Northern, NJ (Hybrid – 3 days/week onsite)Salary: $270K–$350K + BonusThis senior leadership role is responsible for developing and executing global regulatory strategies for neurology drug programs at a fast-growing, research-driven pharmaceutical company. Success in this role requires at least 12 years of regulatory affairs experience in the biopharma industry, a strong understanding of global regulatory requirements, and a proven track record of managing submissions for major markets.

Daiichi Sankyo, Inc.

Bernards, NJ

With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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.

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.

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.

DCS Corporation

Alexandria, VA

Headquartered in Alexandria, VA, DCS is a mid-tier, privately held company with over 2,000 employees and 17 offices throughout the U.S. The General Counsel is expected to lead and manage a strategic, proactive, efficient, business-focused, and service-oriented legal function, demonstrating a mindset and practice that is both consultative and solutions-driven. Minimum of 15 years of experience in corporate law departments and/or regional/national law firms providing services directly to corporate clients, including: Law degree with license to practice law in a U.S. jurisdiction with eligibility to be admitted as Corporate Counsel in the Commonwealth of Virginia.

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 (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.

Syncromune, Inc.

$160000 - $180000

Fort Lauderdale, FL

Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education. The Senior Manager of Regulatory Affairs will assist in all facets of the company’s Regulatory Affairs for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities.

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.

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.

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.

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).

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. 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.

Hamilton Medical, Inc.

Reno, Nevada

Proven track record of authoring, reviewing, and approving high-quality 510(k) submissions, including substantial equivalence arguments, intended use, labeling, and responses to FDA deficiencies. Lead and oversee all formal FDA engagements, including Pre-Submissions (Q-Subs), submission meetings, interactive reviews, deficiency responses, and appeals.