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Regulatory Affairs Jobs in Pennsylvania

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Principal, Regulatory Affairs Intelligence West Pharmaceutical Services

Exton, PA

West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. This role requires deep expertise in global regulatory frameworks, with a specialized focus on containment systems (i.e., primary packaging), pharmaceutical manufacturing and handling, and regulatory requirements applicable to drugs and drug constituents of combination products.

25 days ago

Principal Regulatory Affairs Project Manager, Medical Devices West Pharmaceutical Services

Exton, PA

West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.

25 days ago

Director Medical Affairs - Clinical Microbiology Waters Corporation

Philadelphia, PA

The Director is expected to bring deep diagnostic and laboratory expertise, strong business acumen, and a collaborative leadership style to advance medical credibility, innovation, and patient impact across Waters Advanced Diagnostics. This individual translates unmet customer and patient needs, evolving clinical practice, and real-world evidence into actionable medical strategies that strengthen product differentiation, support lifecycle decisions, and enable successful development and adoption of innovative diagnostic solutions.

25 days ago

Manager, Drug Product Manufacturing Larimar Therapeutics

Philadelphia, PA

Quick Apply

The successful candidate will provide technical leadership across drug product manufacturing, process validation, lifecycle management, and commercialization efforts while partnering closely with Technical Operations, MSAT, Quality, Regulatory Affairs, Supply Chain, Process Development, and external partners. Reporting to the Head of Drug Product, CMC Technical Operations, the Manager/Senior Manager, Drug Product Manufacturing is responsible for overseeing external manufacturing operations and technology transfer activities for lyophilized biologic drug products supporting clinical and commercial supply.

30+ days ago

Senior Principal Statistician Jazz Pharmaceuticals

Philadelphia, PA

Remote

$156,000–$234,000 / year

Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis. 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.

30+ days ago

Sr. Principal Statistician, Biostatistics Jazz Pharmaceuticals

Philadelphia, PA

Remote

$156,000–$234,000 / year

30+ days ago

Senior Manager, Program Management CSL

King of Prussia, PA

Owns the Project Management and Process framework of key enterprise-wide initiatives such as Advisory Boards and cross-functional strategic initiatives (eg evidence gap analysis) and ensure alignment of scope, timelines, decision points, risks and accountabilities across 3M (Marketing, Medical, Market Access) strategic activities and other key functions such as R&D. This role leads end-to-end medical program management for the assigned portfolio, including annual planning, budget and resource coordination, governance, and delivery of key medical affairs outputs (insight and evidence generation plans, publication planning, and medical strategy documents), ensuring the alignment across global, regions, and key functions.

11 days ago

Policy Associate Powering Prosperity

United, WV

Remote

$90,000–$140,000 / year

Particularly relevant backgrounds may include: State legislative or governors’ offices Regulatory/technical (public utility commissions, RTOs, energy or regulatory advocates/law firms, etc.) Political or issue advocacy campaigns Government affairs or public affairs firms State-based advocacy organizations Trade associations Think tanks or nonprofit policy organizations Electric utilities Oil and gas companies Independent power producers Energy infrastructure companies Previous energy experience is a plus, but not a requirement. What We're Looking For 2–5 years of experience in public policy, legislative affairs, government affairs, utility regulatory proceedings (e.g., experience at or advocating before a public utility commission), research, advocacy, think tanks, public affairs, or a related field; exceptional early-career candidates may also be considered.

1 day ago

Medical Director, GI Oncology and Solid Tumors Jazz Pharmaceuticals

Philadelphia, PA

Remote

$216,000–$324,000 / year

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 Medical Director (MD) will provide leadership and direction to a cross functional Medical Affairs team in the development and execution of the Medical Affairs plans and collaborate with the brand team and Clinical Development in the strategic planning and life cycle management of marketed and in-development products.

1 day ago

Associate Director, Regulatory Affairs - Power Platform Solutions Specialist Merck & Co Inc

North Wales, PA

$129,000–$203,100 / year

Required Skills: Business Applications Development, Change Controls, Data Engineering, Defects Management, Microsoft Dataverse, Microsoft Power Apps, Microsoft Power Automate, Microsoft Power Platform Copilot, Problem Solving, Release Management, Root Cause Analysis (RCA), Software Testing, Technical Troubleshooting. Identify opportunities to improve the current system, bring innovative enhancement ideas, remain versed in new and emerging Power Platform tools, design capabilities, and user-interface development approaches supporting modernized Power Apps UI and usability, efficiency, and long-term platform value.

23 days ago

Associate Director, Regulatory Affairs Teva Pharmaceutical Industries Ltd

West Chester, PA

$139,920–$174,900 / year

Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) leads the regulatory review, strategy, and approval of promotional and non-promotional communications for assigned marketed and development products, serves on the Promotion and Advertising Review Committees (PARC) and Medical Legal Regulatory (MLR) Review Committees, provides expert guidance on OPDP requirements and enforcement trends, and partners cross-functionally with Commercial, Medical, Legal, and other functions to ensure that all product communications are scientifically accurate, balanced, truthful and non-misleading, and compliant with applicable regulations while supporting business objectives. Serve as the regulatory reviewer for promotional and educational materials for assigned products, including HCP-directed materials (detail aids, journal advertising, congress materials, disease state education), DTC materials (television, digital, print, social media), payer-focused materials (AMCP dossiers, budget impact tools), and internal training materials.

2 days ago

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals Inc

Philadelphia, PA

$170,900–$231,300 / year

The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.

30 days ago

Associate Director, Regulatory Affairs, CMC- Biologics Alnylam Pharmaceuticals Inc

Philadelphia, PA

$170,900–$231,300 / year

Lead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities. This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies.

30 days ago

Associate Director, Regulatory Affairs, Cmc- Biologics Alnylam Pharmaceuticals, Inc.

Philadelphia, PA

30+ days ago

Manager, Product Stewardship & Regulatory Affairs Azelis

West Chester, Pennsylvania

Teamwork- Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Problem Solving- Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

16 days ago

Senior Manager Global Regulatory Affairs CMC CSL Behring LLC

King of Prussia, PA

Products is responsible for: Partnering closely with CSL's R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.

9 days ago

Senior Director, Regulatory Affairs Immunocore Holdings Plc

Radnor, PA

$250,000–$270,000 / year

Vacancy NameSenior Director, Regulatory Affairs Vacancy NoVN870 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore's development programs to include regulatory scientific and tactical strategy development, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. $250,000- $270,000 About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease.

30+ days ago

Director of Regulatory Affairs University of Pittsburgh

Pittsburgh, PA

Based Upon Qualifications'',''TBD Based Upon Qualifications'',''No'',''No'',''Yes'',''Yes'',''For position finalists, employment with the University will require successful completion of a background check'',''For position finalists, employment with the University will require successful completion of a background check'',''Not Applicable'',''Not Applicable'',''Resume'',''Resume'',''Cover Letter'',''Cover Letter'',''false'',''452724'',''452724'',''true'',''452724'',''false'',''Submission for the position: Director of Regulatory Affairs - (Job Number: 26006426)'',''false'',''452724'',''false'',''true''. The Pulmonary, Allergy, Critical Care, and Sleep Medicine Division is made of up approximately 70 clinical staff and over 100 research staff who work in a variety of locations including: Bridgeside Point, Biomedical Science Tower (BST), UPMC Hospitals including Presbyterian, Shadyside, East, Jameson and Mercy.

10 days ago

Director, US Regulatory Affairs, Advertising & Promotion Cytokinetics

Radnor, Pennsylvania

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. The Director Regulatory Affairs, Advertising and Promotion plays a critical role in providing strategic regulatory leadership and oversight for commercial, promotional, and medical communications.

30+ days ago

Senior Director, Quality Assurance & Regulatory Affairs ConcertAI

Plymouth Meeting, PA

ConcertAI brings together a portfolio of purpose-built solutions, including TeraRecon, an industry leader in advanced imaging and AI-driven visualization, and CancerLinQ, the ASCO-originated oncology platform advancing care quality and large-scale discovery. Leaders are expected to embrace an AI-first mindset by leveraging AI to improve efficiency, enhance quality, automate routine work, accelerate decision-making, and foster continuous innovation while ensuring responsible, ethical, and compliant use of AI technologies.

30+ days ago

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Regulatory Affairs Jobs in Pennsylvania

Principal, Regulatory Affairs Intelligence West Pharmaceutical Services

Principal Regulatory Affairs Project Manager, Medical Devices West Pharmaceutical Services

Director Medical Affairs - Clinical Microbiology Waters Corporation

Manager, Drug Product Manufacturing Larimar Therapeutics

Senior Principal Statistician Jazz Pharmaceuticals

Sr. Principal Statistician, Biostatistics Jazz Pharmaceuticals

Senior Manager, Program Management CSL

Policy Associate Powering Prosperity

Medical Director, GI Oncology and Solid Tumors Jazz Pharmaceuticals

Associate Director, Regulatory Affairs - Power Platform Solutions Specialist Merck & Co Inc

Associate Director, Regulatory Affairs Teva Pharmaceutical Industries Ltd

Associate Director, Regulatory Affairs Alnylam Pharmaceuticals Inc

Associate Director, Regulatory Affairs, CMC- Biologics Alnylam Pharmaceuticals Inc

Associate Director, Regulatory Affairs, Cmc- Biologics Alnylam Pharmaceuticals, Inc.

Manager, Product Stewardship & Regulatory Affairs Azelis

Senior Manager Global Regulatory Affairs CMC CSL Behring LLC

Senior Director, Regulatory Affairs Immunocore Holdings Plc

Director of Regulatory Affairs University of Pittsburgh

Director, US Regulatory Affairs, Advertising & Promotion Cytokinetics

Senior Director, Quality Assurance & Regulatory Affairs ConcertAI

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