337 Results for

Regulatory Affairs Jobs in Raleigh, NC

Jobs

Durham, NC

Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.

Today

Durham, NC

Today

Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

19 days ago

Research Triangle Park, NC

30+ days ago

Durham, NC

$28–$35 / hour

Ability to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications. Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.

22 days ago

Durham, NC

$60,000–$85,000 / year

The Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions.

4 days ago

li>Provide regulatory support for assigned products/projects, coordinating cross-functional activities with various UTC product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) to support execution of regulatory activities and adherence to established timelines.

The Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics will lead regulatory activities for assigned existing and new programs, supporting product development from early development through post-approval.

30+ days ago

Durham, NC

$28–$35 / hour

li>Ability to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications.

Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.

22 days ago

Durham, NC

$28–$35 / hour

Ability to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications. ● Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.

22 days ago

Clayton, NC

$28–$35 / hour

The culture emphasizes collaboration, integrity, and continuous learning, offering strong training resources, exposure to advanced scientific and regulatory practices, and a supportive environment where your work directly contributes to improving patient lives. You will work in a professional office environment that supports plasma regulatory affairs activities, using tools such as Microsoft Office (Word, Excel) and Adobe PDF for document creation, editing, and formatting.

21 days ago

Morrisville, NC

The Associate Director Regulatory Affairs CMC possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs beyond CMC, across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

30+ days ago

li>Coordinate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content.

Job Summary:

Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client''s Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team.

4 days ago

Research Triangle Park, NC

The Associate Director, Regulatory Affairs (CMC) possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs (beyond CMC) across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies. We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

30+ days ago

Durham, NC

$138,750–$231,250 / year

This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.

9 days ago

You'll serve as the primary regulatory expert across multiple clinical studies, working shoulder‑to‑shoulder with cross‑functional teams and client stakeholders to enable compliant, efficient trial execution. As a Regulatory Affairs Consultant in a dedicated client partnership, you'll play a critical role in making that mission real-guiding complex clinical studies through the regulatory landscape with rigor, insight, and collaboration.

30+ days ago

Raleigh, NC

$176,000–$242,000 / year

Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. May participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc.).May provide direct supervision of individuals including mentoring, performance management and staffing decisions.

30+ days ago

Morrisville, NC

$203,000–$253,000 / year

The position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth.

The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions.

6 days ago

Raleigh, NC

The individual will oversee or represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and must possess a thorough knowledge of regulations for medical affairs activities, advertisement and promotional compliance governing drugs, device, cosmetic, and combination products and the ability to translate regulatory requirements into decision-ready guidance for senior stakeholders. Lead the team within Global Regulatory Affairs that provides strategic regulatory expertise and guidance to global internal leaders and stakeholders regarding the marketing of products including review of advertising, promotional and other related materials to ensure compliance with applicable regulations and guidance documents.

28 days ago

Durham, NC

The Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.

30+ days ago

Durham, NC

Works with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products.

Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing.

30+ days ago

Durham, NC

Required: Master's degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences or related field plus 3 years of experience in the job offered, as Regulatory Engineer or related regulatory affairs position within the medical and/or diagnostic device industry. Duties: Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.

21 days ago

Raleigh, NC

li>Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices .

Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.

Today

Durham, NC

Included among the necessary activities are: oversight of regulatory CRO activities, planning and leading: meetings with regulatory authorities, compilation and submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, responses to information requests and questions, safety reports, and annual updates/DSURs for assigned projects.

30+ days ago

Durham, NC

Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.

Today

Research Triangle Park, NC

$21–$22 / hour

Minimum RequirementsCurrently enrolled in a Masters of Pharmaceutical Sciences Regulatory Sciences Program with at least one semester of coursework completed · Strong understanding of drug development processes and regulatory frameworks · Basic understanding of Health and Human Services (HHS), and Food and Drug Administration (FDA) · Excellent English written and verbal communication skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) · Strong attention to detail and organizational skills · Ability to work both independently and collaboratively in a team environment · Demonstrated interest in cell and gene therapy or biologics regulation.

30+ days ago

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

30+ days ago

You will play a key leadership role in managing midsize to large Regulatory Affairs outsourcing programs, partnering closely with clients and cross-functional teams to drive operational excellence, ensure delivery against regulatory objectives, and support the successful progression of development and commercial programs.

Due to continued growth and the ongoing success of our Regulatory Affairs Consulting team, Parexel is seeking an experienced Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) to join our team.

22 days ago

Durham, North Carolina

As a Senior Regulatory Affairs Specialist, you will play a key role in shaping regulatory strategies that enable the successful development and commercialization of biofertilizers, plant inoculants, and biocontrol solutions. As part of our Global Regulatory Affairs function, you will join a collaborative and high-impact team supporting the registration and legal sale of Plant Biosolutions worldwide.

8 days ago

Raleigh, North Carolina

Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices. Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.

19 days ago

This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk. We are seeking a highly strategic and experienced Senior Regulatory Consultant - Advertising & Promotion to serve as a trusted advisor across cross-functional teams.

30+ days ago

Raleigh, NC

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Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements.

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.

23 days ago

Raleigh, NC

Brief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.

30+ days ago

Durham, NC

$113,850–$189,750 / year

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

9 days ago

Clayton, NC

Summary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.

26 days ago

Raleigh, NC

As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.

6 days ago

Raleigh, NC

12 days ago

Durham, NC

Remote

$115,000–$130,000 / year

The Regulatory Affairs Project Manager will be responsible for developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.

University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

14 days ago

Raleigh, North Carolina

Peregrine Team is seeking a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance across pharmaceutical products. This role will work closely with cross-functional teams to support product approvals and lifecycle management.

30+ days ago

Raleigh, NC

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne's development programs, from early-stage development through commercialization and post-approval lifecycle management. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

30+ days ago

Durham, NC

22 days ago

$145,500–$205,000 / year

Bachelor's Degree in business, finance, life sciences, healthcare, information systems or related field with 12+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech) or, Master's Degree with 10+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech). The Associate Corporate Compliance Director reports to the Senior Corporate Compliance Director and serves as a key compliance business partner to Commercial and Medical Affairs, including Sales, Marketing, Commercial Training and Development, Patient Advocacy, and Medical Affairs.

30+ days ago

Wake Forest, North Carolina

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Regulatory Affairs Jobs in Raleigh, NC

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Regulatory Affairs Jobs in Raleigh, NC

Banking Center Manager II First Horizon Bank

Banking Center Manager First Horizon Bank

Regulatory Affairs Associate (entry level) Grifols SA

Plasma Regulatory Affairs Associate Grifols SA

Plasma Regulatory Affairs Associate The Kemtah Group, Inc.

Regulatory Affairs Specialist (CMC) Zp Group Llc

Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics United Therapeutics Corp

Plasma Regulatory Affairs Associate Belcan LLC

Plasma Regulatory Affairs Associate Belcan

Regulatory Affairs Associate Actalent Inc

Associate Director, Regulatory Affairs (CMC) Kriya Therapeutics Inc

Regulatory Affairs Specialist Zp Group Llc

Associate Director, Regulatory Affairs (CMC) Kriya Therapeutics

Associate Director Regulatory Affairs, Oncology GSK plc

Regulatory Affairs Consultant - Clinical Regulatory Affairs Parexel International Corp

Associate Director, Regulatory Affairs Baxter International Inc

Sr. Director, Strategic Regulatory Affairs and UDI Teleflex Inc

Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs Merz North America Inc

Sr. Regulatory Affairs Specialist Bioventus Inc

Manager Regulatory Affairs Bioventus Inc

Senior Regulatory Affairs Specialist Bioventus Inc

Senior Manager, Regulatory Affairs (Ad Promo) ICON PLC

Director (Senior Director), Regulatory Affairs Shattuck Labs Inc

Sr. Regulatory Affairs Specialist Bioventus

Intern Regulatory Affairs Leadstack Inc

Sr. Regulatory Affairs Manager Validation & Engineering Group

Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) Parexel International Corp

Senior Regulatory Affairs Specialist - Plant Health Novonesis

Senior Manager, Regulatory Affairs (Ad Promo) IRE

Senior Regulatory Affairs Consultant - Ad Promo Parexel International Corp

Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - US

Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals Inc

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

Manager/Sr. Manager, Regulatory Affairs (Labeling) Grifols SA

Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - US

Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals Inc

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Regulatory Affairs Specialist Peregrine Team

Director, Regulatory Affairs CMC ProPharma Group Holdings LLC

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Associate Corporate Compliance Director - Commercial & Medical Affairs United Therapeutics Corp

Vice Chair of Research Affairs and Section Chief of Comparative Medicine Department of Pathology Advocate Health and Hospitals Corporation

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Senior Medical Director , US Immunology Medical Affairs Swedish Orphan Biovitrum AB

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