1,249 Results for

Regulatory Affairs Jobs in Westlake, MD

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Vice President Quality and Regulatory Affairs Clinical Dynamix, Inc.

Germantown, MD

Quick Apply

This executive will have overall responsibility for establishing and maintaining a phase-appropriate Quality Management System, providing strategic regulatory leadership, and ensuring compliance across clinical development, manufacturing, testing, and external partners. The VP will serve as a key member of the leadership team and will work closely with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external partners to advance programs through clinical development and toward commercialization.

1 day ago

Fractional CLIA Laboratory Director Staff Icons

Washington, DC

Full time
Quick Apply

The company is actively advancing its investigational diagnostic technology toward an FDA 510(k) submission and is seeking an accomplished laboratory leader to provide scientific, technical, operational, and quality oversight during this important development phase. If you are an experienced Molecular Pathologist or PhD laboratory scientist with molecular diagnostics expertise and an interest in fractional laboratory leadership, we would welcome a confidential conversation.

15 days ago

Manager, Process Development / Mfg. Science & Technology, Cell Theray Clinical Dynamix, Inc.

Germantown, MD

Quick Apply

The successful candidate will provide technical leadership across process development initiatives, mentor junior scientists and process engineers, and ensure rigorous, well-documented, GMP-compliant workflows — partnering closely with R&D, Manufacturing, Quality, Regulatory, and Clinical teams to advance novel immunotherapy products toward the clinic. We are committed to translating cutting-edge science into impactful therapies for patients with cancer and are seeking talented scientists to help drive our growing pipeline of immunotherapy and cell therapy programs.

Today

Float Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.

Washington, DC

Quick Apply

Perform physical examinations with special emphasis on the reproductive system, including breast examination, pelvic examination, cancer screening tests, diagnosis of sexually transmitted infections (STIs), and other types of more specialized procedures as may be indicated by medical policy. Collaborate with the health team and other community agencies and resources (e.g., physicians, local health departments, social service, nutritionists, dentists, and parent education groups), through joint planning and coordination of activities, in providing comprehensive care.

3 days ago

Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.

Washington, DC

Today

Senior Director, Advocacy and Practice Advancement Society of Interventional Radiology

FAIRFAX, VA

$165,000–$180,000 / year

Working closely with physician leaders, volunteers, external stakeholders, and senior staff, the Senior Director helps shape strategies that advance the specialty of interventional radiology within the rapidly evolving U.S. healthcare system. Minimum of 8-10 years of progressive leadership experience in healthcare policy, healthcare delivery, physician practice strategy, healthcare consulting, payer relations, advocacy, or association management.

3 days ago

Head Of US Regulatory Affairs Advertising And Promotion, Global Regulatory Affairs Viatris Inc.

Washington, DC

$151,000–$314,000 / year

With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. Serve as the primary contact with the FDA's Office of Prescription Drug Promotion (OPDP) within the U.S. Food and Drug Administration; lead submissions, risk mitigation strategies, and regulatory interactions including advisory comments, Form FDA 2253 submissions, and responses to regulatory enforcement actions.

30+ days ago

Manager, Regulatory Affairs Labeling Supernus

Rockville, MD

$110,000–$135,000 / year

Job Summary: The Manager of Regulatory Affairs Labeling is responsible for the development, review, and approval of commercial product labeling (Prescribing Information, Patient Information, Medication Guides, and Instructions for Use) and printed component artwork (cartons, container labels, blister foils and pouches) across the assigned Supernus commercial portfolio. This role partners with Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, Supply Chain, and external graphic and packaging vendors to ensure all labeling and artwork content is accurate and compliant with FDA regulations and ICH guidelines.

27 days ago

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals Inc

Rockville, MD

$110,000–$135,000 / year

27 days ago

Associate Director, Regulatory Affairs RegenxBio Inc

$160,000–$218,000 / year

As Associate Director, Regulatory Affairs, you''ll lead global regulatory strategy for a therapeutic area from early development through marketing authorization - translating complex requirements into clear paths forward, shaping health authority interactions, and partnering across functions to keep programs moving. We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, paid caregiver leave, retirement plan with employer match, stock options at all levels, summer hours and more!

30+ days ago

Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge

District of Columbia

Reporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders. The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.

30+ days ago

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals

Rockville, Maryland

The Manager of Regulatory Affairs Labeling is responsible for the development, review, and approval of commercial product labeling (Prescribing Information, Patient Information, Medication Guides, and Instructions for Use) and printed component artwork (cartons, container labels, blister foils and pouches) across the assigned Supernus commercial portfolio. This role partners with Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, Supply Chain, and external graphic and packaging vendors to ensure all labeling and artwork content is accurate and compliant with FDA regulations and ICH guidelines.

27 days ago

Sr. Regulatory Affairs Specialist VB Spine

Leesburg, Virginia

$100,000–$105,000 / year

At VB Spine, join a high-performing team where you’ll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance — positioning yourself for continued growth in a dynamic, mission-driven medical device company. The typical pay range for this position is $100,000.00 - $105,000.00 annually, with potential for bonuses and incentives plus benefits.

30+ days ago

Sr. Regulatory Affairs Specialist VB Spine LLC

Leesburg, VA

$100,000–$105,000 / year

As a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.

30+ days ago

Senior Counsel, Regulatory Affairs and Policy The PNC Financial Services Group Inc

Washington, DC

$159,600–$296,400 / year

Participating in the preparation and oversight of regulatory filings related to new business initiatives and interpretive requests related to new products and services; Providing specialized legal advice and counsel to attorneys supporting the lines of business on a wide array of regulatory issues in support of the company's efforts to achieve its business goals in compliance with law and regulation. The position is based in Washington D.C. Responsibilities include: Serving as a key team player and legal advisor on an array of statutes, regulations, and guidance governing PNC's business and operations, including those at the bank, the holding company and their affiliates; Advising on and advocating for legal and policy considerations associated with prudential regulations, including Basel III capital, liquidity, tailoring and other related regulations.

3 days ago

Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions Inc

Washington, DC

$180,000–$190,000 / year

30+ days ago

Senior Counsel, Regulatory Affairs and Policy PNC Bank

District of Columbia

Participating in the preparation and oversight of regulatory filings related to new business initiatives and interpretive requests related to new products and services; - Providing specialized legal advice and counsel to attorneys supporting the lines of business on a wide array of regulatory issues in support of the company’s efforts to achieve its business goals in compliance with law and regulation. The position is based in Washington D.C. Responsibilities include: - Serving as a key team player and legal advisor on an array of statutes, regulations, and guidance governing PNC’s business and operations, including those at the bank, the holding company and their affiliates; - Advising on and advocating for legal and policy considerations associated with prudential regulations, including Basel III capital, liquidity, tailoring and other related regulations.

3 days ago

Sr. Engineer, Regulatory Affairs and Certification, Vehicle Safety Mitsubishi Motors North America, Inc.

Washington, DC

While most day-to-day interactions will be conducted virtually, this position requires a proactive communicator who can effectively engage in a hybrid environment, balance independent remote work and occasional on-site presence with internal and external stakeholders to support team alignment and relationship-building. Interact with entities including but not limited to NHTSA, IIHS, NTSB, Consumer Reports (CR), the Alliance for Automotive Innovation (AAI), other vehicle manufacturers, Mitsubishi North American Affiliate offices (MMNA and MMSCan), and Mitsubishi Motors Corporation (MMC).

30+ days ago

Government Accounting Compliance and Regulatory Affairs Analyst ManTech International Corp

$54,700–$90,300 / year

There are differentiating factors that can impact a final salary/hourly rate, including, but not limited to, Contract Wage Determination, relevant work experience, skills and competencies that align to the specified role, geographic location (For Remote Opportunities), education and certifications as well as Federal Government Contract Labor categories. MANTECH's benefits offerings include, dependent upon position, Health Insurance, Life Insurance, Paid Time Off, Holiday Pay, short-term and long-term Disability, Retirement and Savings, Learning and Development opportunities, wellness programs as well as other optional benefit elections.

30+ days ago

Sr. Satellite Policy Associate (Starlink Regulatory Affairs) SpaceX

Washington, DC

$190,000–$245,000 / year

Our customers currently include teachers in the most remote parts of the Amazon, researchers in Antarctica, digital nomads who travel via RV, emergency responders, commercial airlines, cruise lines, and residential users who live in more rural or developing areas. To conform to U.S. Government export regulations, applicant must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent resident (aka green card holder), (iii) Refugee under 8 U.S.C. § 1157, or (iv) Asylee under 8 U.S.C. § 1158, or be eligible to obtain the required authorizations from the U.S. Department of State.

30+ days ago

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Regulatory Affairs Jobs in Westlake, MD

Vice President Quality and Regulatory Affairs Clinical Dynamix, Inc.

Fractional CLIA Laboratory Director Staff Icons

Manager, Process Development / Mfg. Science & Technology, Cell Theray Clinical Dynamix, Inc.

Float Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.

Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.

Senior Director, Advocacy and Practice Advancement Society of Interventional Radiology

Head Of US Regulatory Affairs Advertising And Promotion, Global Regulatory Affairs Viatris Inc.

Manager, Regulatory Affairs Labeling Supernus

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals Inc

Associate Director, Regulatory Affairs RegenxBio Inc

Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals

Sr. Regulatory Affairs Specialist VB Spine

Sr. Regulatory Affairs Specialist VB Spine LLC

Senior Counsel, Regulatory Affairs and Policy The PNC Financial Services Group Inc

Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions Inc

Senior Counsel, Regulatory Affairs and Policy PNC Bank

Sr. Engineer, Regulatory Affairs and Certification, Vehicle Safety Mitsubishi Motors North America, Inc.

Government Accounting Compliance and Regulatory Affairs Analyst ManTech International Corp

Sr. Satellite Policy Associate (Starlink Regulatory Affairs) SpaceX

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