regulatory affairs Jobs

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Assistant Director Regulatory AffairsJob Title - Assistant Director Regulatory Affairs

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Eden Prairie, Minnesota, USA

Full-time

Piper Companies is looking for an Assistant Director of Regulatory Affairs to join a biotechnology company focusing on products to address life threatening conditions. This is a full-time position and onsite in Eden Prairie, MN (relocation assistance available). Essential Duties of the Assistant Director of Regulatory Affairs: Main point person responsible for writing INDs. 50-60% of time will be writing related. Writing sections of IND with support of cross functional teams. Opportunity to gai

Associate Director of Regulatory AffairsJob Title - Associate Director of Regulatory Affairs

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Eden Prairie, Minnesota, USA

Full-time

Piper Companies is currently looking for an experienced Associate Director of Regulatory Affairs in Eden Prairie, Minnesota (MN) to work for an innovative and growing pharmaceutical manufacturer. (Relocation Assistance Available) Responsibilities for the Associate Director of Regulatory Affairs include: Contribute to and execute the overall regulatory strategy for new and existing products, ensuring compliance with global regulations. Act as main contributor in the drafting of IND Submission doc

Regulatory Affairs - Labeling Strategy, Senior ManagerJob Title - Regulatory Affairs - Labeling Strategy, Senior Manager

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Atlanta, Georgia, USA

Full-time

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This is a hybrid position and the ideal candidate will be located in the Atlanta, GA or Raleigh, NC regions. Responsibilities of the Labeling Strategy, Senior Manager: Develop

Regulatory Affairs - Labeling Strategy, Senior ManagerJob Title - Regulatory Affairs - Labeling Strategy, Senior Manager

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Raleigh, North Carolina, USA

Full-time

Regulatory Affairs ManagerJob Title - Regulatory Affairs Manager

LMI Government Consulting (Logistics Management InCompany Name - LMI Government Consulting (Logistics Management In

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Frederick, Maryland, USA

Contract

Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/NACI securit

Regulatory affairs - CMC ManagerJob Title - Regulatory affairs - CMC Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product su

Regulatory affairs - CMC ManagerJob Title - Regulatory affairs - CMC Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

Intern - Regulatory Affairs, CMCJob Title - Intern - Regulatory Affairs, CMC

Mitchell Martin, Inc.Company Name - Mitchell Martin, Inc.

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Montgomery, Alabama, USA

Full-time, Contract

Title: Intern - Regulatory Affairs, CMCLocation: Regional description (Onsite) Employment Type: ContractCompensation Pay Range:$22.05-$31.50/HrsDescription: * Support regulatory projects by collaborating with cross-functional teams. * Develop a deeper understanding of drug development and regulatory requirements. * Gain exposure to global Regulatory Affairs and CMC Regulatory Affairs. * Learn about the role of global Health Authorities in drug development. * Prepare regulatory documents for subm

Pharma Global Regulatory Affairs IT Solution ArchitectJob Title - Pharma Global Regulatory Affairs IT Solution Architect

PozentCompany Name - Pozent

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No location provided

Contract

Responsibilities: Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Collaborate with business stakeholders to understand requirements and translate them into scalable, compliant, and efficient technology solutions. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pip

Senior Regulatory Affairs SMEJob Title - Senior Regulatory Affairs SME

LMI Government Consulting (Logistics Management InCompany Name - LMI Government Consulting (Logistics Management In

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Remote

Contract

Overview LMI is seeking a Senior Regulatory Affairs SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates w

Regulatory Affairs SpecialistJob Title - Regulatory Affairs Specialist

IKCON TECHNOLOGIES Inc.Company Name - IKCON TECHNOLOGIES Inc.

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New Jersey, USA

Contract, Third Party

IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for a Regulatory Affairs Specialist with one of our clients in Remote, Remote. If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE Regulatory Affairs Specialist/Senior Specialist for Drug-Device Combination Products CITY Remote STATE

Project Manager, Digital Health Product Strategy & Operations (HIV)Job Title - Project Manager, Digital Health Product Strategy & Operations (HIV)

I.T. SolutionsCompany Name - I.T. Solutions

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Foster City, California, USA

Contract

Job Title: Project Manager, Digital Health Product Strategy & Operations (HIV) Location: Foster City, California (Onsite 3 days a week) Duration: 6 Months + Likely Extensions Key Responsibilities: As the Project Manager, Digital Health Product Strategy & Operations for HIV, you will play a crucial role in enabling the success of our digital health initiatives by managing key projects and supporting Product leadership. Your responsibilities include:Digital Health Initiative Management: Directly s

Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Jersey City, New Jersey, USA

Full-time

Responsibilities: This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site. Develop and execute current state operational readiness assessment pFMEAs. Report findings with recommendations and escalate critical risks/gaps identified timely. Support resolution of identified gaps, id

Senior Process EngineerJob Title - Senior Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Regulatory Solutions ArchitectJob Title - Regulatory Solutions Architect

INGENworksCompany Name - INGENworks

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Atlanta, Georgia, USA

Contract

Regulatory Solutions Architect Location: RemoteDuration: Long Term Required Qualifications:Bachelor s or Master s degree in Computer Science, Regulatory Affairs, Life Sciences, or a related field.7+ years of experience in Regulatory IT or Regulatory Affairs, including 3+ years as an Architect or Lead.Proven experience working with Commercial Regulatory Affairs systems (e.g., labeling, promotional compliance, Veeva PromoMats, MedComms).In-depth knowledge of regulatory requirements in US, EU, and

Validation Engineer IIJob Title - Validation Engineer II

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Athens, Georgia, USA

Full-time

Responsibilities: Perform Smoke studies and assist in semiannual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas. Has worked with Ellabs data loggers and software. Write and execute protocols and complete final reports. Understanding of cleaning validation concepts and principles. Understands pharma grade utilities (water HVAC, gases). Requirements: Support Maintenance, Engineering

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and

Information Security Risk AnalystJob Title - Information Security Risk Analyst

Digitek Software, Inc.Company Name - Digitek Software, Inc.

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Charlotte, North Carolina, USA

Third Party, Contract

One of our clients is looking Technical Specialist with following skills: The client is seeking a skilled Information Security Risk Analyst on a contract basis to lead the execution of its annual enterprise security risk assessment. This engagement ensures compliance with industry-standard frameworks, supports proactive risk mitigation, & positions NC HIEA for future HITRUST certification. Plan and conduct NC HIEA s annual enterprise security risk assessment using NIST SP 800-30, ISO 27005, or F

Systems EngineerJob Title - Systems Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Skaneateles, New York, USA

Full-time

Responsibilities: Responsible for integration of design and manufacturing process procedures, templates and guidance documents within an ISO 13485 compliant Quality Management System (QMS). Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.). Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs. Demonstrated understanding of Syste

Engineer, Principal Regulatory - License Renewal & Power UprateJob Title - Engineer, Principal Regulatory - License Renewal & Power Uprate

Constellation EnergyCompany Name - Constellation Energy

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Warrenville, Illinois, USA

Full-time

WHO WE ARE As the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Our culture and employee experience make it clear: We are powered by passion and purpose. Together, we're creating healthier communities and a cleaner planet, and our