Regulatory Affairs jobs in Pennsylvania

Global Regulatory Affairs Core Labeling with Pharma/Biotech experience

Remote

•

Today

JOB DESCRIPTION: We are seeking an experienced Global Regulatory Labeling professional to lead strategic and operational labeling activities across the product lifecycle. The Senior Manager, Core Labeling will be responsible for the development, maintenance, and implementation of global core labeling documents including CCDS, USPI, EU SmPC, and associated patient information while ensuring compliance with global regulatory requirements. This role partners cross-functionally with Regulatory Affai

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Contract

$60 - $70

Project Manager, Regulatory Affairs (Clinical and CMC)

Remote

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5d ago

Title: Project Manager, Regulatory Affairs (Clinical and CMC) Location: Remote Position Type: Contract Compensation Pay Range:$58.80-$84.00 Per hr Description Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC. This remote contract role involves leading cross-functional regulatory activities, enhancing project management standards, and mentoring junior project managers. Proficiency in project management and regulatory systems is essential. Key Responsibilit

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Contract, Third Party

$58.8 - $84

Senior Regulatory Affairs Licensing Engineer (remote eligible)

Remote

•

Today

Job Description Summary The Senior Regulatory Affairs Licensing Engineer will lead the completion of various regulatory work scopes, including working with GVH / GNF Engineering on major projects for the existing fleet of nuclear reactors. Guided by professional practices and policies that are shaped by the role. The role has moderate autonomy, requiring high levels of operational judgment. Job Description Essential Responsibilities As a Senior Regulatory Affairs Licensing Engineer you will: Co

Full-time

USD 111,200.00 - 213,200.00 per year

Regulatory Affairs Engineer

Remote or Indiana

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Today

Accelerate the possible by joining a winning Amcor team that's transforming the packaging industry and improving lives around the world. At Amcor, we unpack possibility through our innovative and responsible packaging to provide solutions that benefit our customers, our people and our planet. More than 10,000 consumers worldwide encounter our products every second and rely on us for safe access to food, medicine and other goods. We value their trust by making safety our guiding principle. It's

Full-time

Public Affairs Specialist

Newtown Square, Pennsylvania

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Today

Energy Transfer, recognized by Forbes as one of America's best large employers, is dedicated to responsibly and safely delivering America's energy. We are driven to inspire our employees to create superior value for our customers, our investors, a sustainable future and giving back to the community where we have long-standing commitments to causes including MD Anderson Children's Cancer Hospital, The Salvation Army, The American Red Cross, Ronald McDonald House and many more. We value all of ou

Full-time

Med Device Auditor

Remote

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7d ago

Job SummaryWe are seeking an experienced and detail-oriented Medical Device Auditor to evaluate and ensure compliance with medical device quality systems, regulatory requirements, and industry standards. The ideal candidate will conduct audits of manufacturing processes, quality management systems, supplier controls, and documentation practices to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulations. The candidate should possess strong analytical skills, deep understandin

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Contract

Depends on Experience

Computer System Validation Engineer

Pennsylvania

•

Today

Job Summary: Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.Roles & Responsibilities: Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, an

Full-time

Regulatory Strategist and Advisor - China Market, Client/Sponsor -Facing

Remote or Almont, Colorado

•

Today

Description: Remote Our client seeks a part-time Regulatory Strategist with deep China market expertise to advise emerging biotech sponsors on early clinical development. The advisor will shape regulatory strategy, inform clinical trial design and country selection for Phases I-II, and prepare teams for China-specific interactions and submissions. The role is client-facing and collaborative with internal teams to strengthen China regulatory advisory capabilities. This engagement is expected to

Contract

Engineer - Aircraft Cybersecurity Operations (Remote)

Remote or Chicago, Illinois

•

Today

Description Connecting People. Uniting the World. There's never been a more exciting time to join United Airlines! As a global company that operates in hundreds of locations around the world - with millions of customers and tens of thousands of employees - we have a unique responsibility to uplift and provide opportunities in the places where we work, live and fly. We're on a path to becoming the best airline in aviation history. Join our Cybersecurity and Digital Risk (CDR) team to help lead t

Full-time

Principal Engineer - Aircraft Cybersecurity Operations (Remote)

Remote or Chicago, Illinois

•

Today

Full-time

CSV Engineer

Pennsylvania

•

Today

Job Summary: The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentatio

Full-time

Sr. Validation Engineer

Allentown, Pennsylvania

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description When you are part of the team at Thermo Fisher, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure

Full-time

Medical/Technical Writer, Scientific Research

Remote or Cincinnati, Ohio

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Today

Kelly Science and Clinical FSP is currently seeking a Medical/Technical Writer for a long-term engagement in Cincinnati, OH with one of our Global Medical Device clients. This role is hybrid and onsite 1-2 days a week. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full-benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 4

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Contract

Refrigeration Service Technician - Commercial & Industrial

Phoenixville, Pennsylvania

•

Today

Overview: WHY COOLSYS? At CoolSys, we offer more than just a job?we provide stability, growth, and industry-leading benefits for our employees. No wonder Newsweek named CoolSys one of America?s Greatest Workplaces! As a large company serving diverse customers, we invest in our team with: Competitive Compensation: $25-$42/hrOngoing Education & Training:Access to state-of-the-art facilities and paid online training.Comprehensive Benefits: Medical, Dental, Vision, and Prescription coverage, paid v

Full-time

Compensation information provided in the description

Lead Engineer - I&C Systems Engineering

Remote or Wilmington, North Carolina

•

Today

Job Description Summary Work on I&C Systems team with a focus on work planning, technical approach, design assurance, and execution excellence from ITO thru OTR on new build and modernization projects. Job Description Essential Responsibilities Lead integrated approaches and solutions across the diverse plant disciplines or specialties of Instrumentation, Control, DCS, HFE, Simulation and Electrical.Coordinate across matrixed Engineering teams to develop I&C system architecture, analyze plant

Full-time

USD 85,600.00 - 164,000.00 per year

Sr Director/Scientific Fellow, AI Safety, R&D Data Science and Digital Health

Remote or Hopewell Township, New Jersey

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 196,000.00 - 342,700.00 per year

Refrigeration Service Technician - Commercial & Industrial

Tamaqua, Pennsylvania

•

Today

Overview: WHY COOLSYS? At CoolSys, we offer more than just a job?we provide stability, growth, and industry-leading benefits for our employees. No wonder Newsweek named CoolSys one of America?s Greatest Workplaces! As a large company serving diverse customers, we invest in our team with: Competitive Compensation: Up to $40/hrOngoing Education & Training:Access to state-of-the-art facilities and paid online training.Comprehensive Benefits: Medical, Dental, Vision, and Prescription coverage, paid

Full-time

Compensation information provided in the description

Systems Engineer IV - Cloud Engineering Lead

Remote or North Charleston, South Carolina

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Today

Leidos is anticipating a new contract award with the Naval Information Warfare Center (NIWC) Atlantic in support of all aspects of the Defense Health Enterprise Application and Desktop Virtualization Support Group, supporting the Clinical Information Modernization (CIM) Integrated Product Team (IPT). The primary customer for this work is the Defense Health Agency (DHA) which consists of a world-wide network of military hospitals, and health clinics, supporting the Department of Defense (DoD) TRI

Full-time

USD 107,900.00 - 195,050.00 per year

SUPERVISORY INTERDISCIPLINARY GENERAL ENGINEER/ARCHITECT (SENIOR DESIGNER)

Philadelphia, Pennsylvania

•

Today

Summary You will serve as a Supervisory Interdisciplinary General Engineer/Architect in the Facilities Engineering & Acquisition Division, Public Works Department Pennsylvania (NBC Philadelphia) of Naval Facilities Engineering Systems Command (NAVFAC) Mid-Atlantic. The organizational title of this position is Senior Designer. Learn more about this agency Duties Help You will provide supervision, assistance and guidance to other designers, engineers/architects, or other NAVFAC codes as appro

Full-time

USD 117,284.00 - 152,471.00 per year

KEMI Administrator - Kren Engineering-based Medicine Institute

Remote or Seattle, Washington

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Today

Job Description UW Medicine and the College of Engineering have an exciting opportunity for a KEMI Administrator. Kren Engineering-based Medicine Institute (KEMI) is catalyzed by a recent donation who saw the great opportunity at University Washington to leverage engineering technologies to develop real solutions for the most pressing challenges in health and healthcare together with UW Medicine. The vision of KEMI is to create an enduring and unparalleled impact by transforming health and hea

Full-time

USD 125,004.00 per year

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Regulatory Affairs jobs in Pennsylvania, USA