1,327 Results for

Regulatory Affairs Jobs in Westlake, MD

Jobs

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.

4 days 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.

20 days ago

Managing Director of Operations & Client Relations Shaw Bransford & Roth P.C.

Washington

$1
Full time

Founded in 1982, Shaw Bransford & Roth P.C. is a boutique employment litigation and government affairs law firm in Washington, D.C. We represent individuals and federal agencies in a wide array of civil and administrative litigation, employment disputes, investigations, security clearance proceedings, and attorney disciplinary matters. Leadership & Soft Skills: Superior organizational abilities, exceptional written and verbal communication, high emotional intelligence, and strong problem-solving skills under tight deadlines.

5 days ago

MERC Senior Program Manager Credence

Washington, DC

Quick Apply

Must have a strong background in the natural sciences or engineering, preferably with a focus in agriculture, natural resources, or water management issues; Must have experience leading, mentoring, or supervising both technical and non-technical staff; Must have experience with the research-funding process, preferably with prior experience in leading a competitive technical grants selection process in an international context, including experience with peer-review panels and assessing complex, multi-faceted research proposals; Must have experience facilitating research collaboration between partners from different countries and cultures, preferably in the Arab-Israeli context, including the political and cultural constraints involved; and. NEA/AC is responsible for coordinating U.S. foreign assistance in the NEA region, including by providing policy direction and operating guidance to officials in Washington and at NEA posts responsible for the implementation of regional assistance programs; overseeing strategic planning, budgeting, and monitoring and evaluation for the Bureau; and providing grants management of foreign assistance awards for the NEA Bureau and overseas NEA posts.

3 days ago

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.

8 days ago

Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.

Washington, DC

Quick Apply

4 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 RD, 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.

4 days ago

Research Director Gables Search Group

Rockville, MD

$190,000–$265,000
Quick Apply

Direct, mentor, and develop a team of 20+ research scientists across molecular biology, assay development, nucleic acids research, and related disciplines. Partner cross-functionally with Product Development, Commercialization, and Regulatory Affairs to translate research into market-ready diagnostic solutions.

5 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

Associate Director, Promotional Regulatory Affairs AstraZeneca Plc

Gaithersburg, MD

$150,098–$225,147 / year

As the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US.

5 days ago

Associate Director, Promotional Regulatory Affairs (BBU) AstraZeneca Plc

Gaithersburg, MD

$150,202–$225,303 / year

30+ days ago

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals Inc

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.

30+ days ago

Manager, Regulatory Affairs Labeling Supernus

Rockville, MD

$110,000–$135,000 / year

30+ days ago

Associate Director, Promotional Regulatory Affairs (BBU) AstraZeneca GmbH

Gaithersburg, MD

$150,202–$225,303 / year

5 days ago

Associate Director, Promotional Regulatory Affairs AstraZeneca GmbH

Gaithersburg, MD

$150,098–$225,147 / year

5 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

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

Washington, DC

$180,000–$190,000 / year

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.

30+ days ago

Sr. Regulatory Affairs Specialist VB Spine

Leesburg, Virginia

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

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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

Managing Director of Operations & Client Relations Shaw Bransford & Roth P.C.

MERC Senior Program Manager Credence

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

Clinician Planned Parenthood of Metropolitan Washington, DC, Inc.

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

Research Director Gables Search Group

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

Associate Director, Promotional Regulatory Affairs AstraZeneca Plc

Associate Director, Promotional Regulatory Affairs (BBU) AstraZeneca Plc

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals Inc

Manager, Regulatory Affairs Labeling Supernus

Associate Director, Promotional Regulatory Affairs (BBU) AstraZeneca GmbH

Associate Director, Promotional Regulatory Affairs AstraZeneca GmbH

Associate Director, Regulatory Affairs RegenxBio Inc

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

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

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals

Sr. Regulatory Affairs Specialist VB Spine

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