Regulatory affairs jobs

San Francisco, California

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21d ago

Title: Director, Regulatory Affairs Location: San Francisco Bay Area (Onsite) Job Description: Reports into Regulatory Affairs, Global Filing & Registration: High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.Develop strate

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Contract

$90 - $100

Global Regulatory Affairs

Remote

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13d ago

Trident Consulting is seeking a " Global Regulatory Affairs Director for one of our client in "Remote". A global leader in business and technology services. Role: Global Regulatory Affairs Director (Global Regulatory Lead) Location: Remote (Must be based in the U.S.)Preferred Time Zone: ESTEmployment Type: Contract (40 hrs/week)Interview: VirtualPriority: High Priority Immediate NeedStart Date: ASAP (Preferred before Sept. 17 18)Pay: $120/hr on w2 Position Summary The Global Regulatory Lead wil

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Contract

$115 - $120

Regulatory Affairs Engineer

Washington

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Today

As a Regulatory Affairs Engineer, a typical day might include the following: Maintain records of global product compliance and associated technical requirements.Track changes to regulatory requirements and determine impacts to SEL.Evaluate and research homologation requirements for markets and technologies.Sustain existing product homologation and certifications.Provide technical assistance as a content expert in worldwide product compliance.Guide engineering staff in translating product complia

Full-time

USD 97,740.00 - 144,460.00 per year

Regulatory Affairs Specialist

Remote

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5d ago

About Nexinfo NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design and advanced software solutions. Our ERP-related services address challenges such as invent

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Contract, Third Party

$60 - $70

Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

Boston, Massachusetts

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Today

At WHOOP, we're on a mission to unlock human performance and extend healthspan. As the leader in wearable health and performance technology, WHOOP empowers millions of members with personalized insights derived from continuous physiological monitoring, advanced analytics, and cutting-edge software experiences. WHOOP is pioneering the future of wearable health technology by combining continuous physiological monitoring, advanced analytics, and intelligent software to help millions of members imp

Full-time

USD 170,000.00 - 220,000.00 per year

Regulatory & Clinical Affairs Manager

Princeton, New Jersey

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5d ago

Role: Regulatory & Clinical Affairs Manager Locations : Princeton, NJ (Onsite) (Full Time /Permanent) Note* FULLTIME Role and This role is on-site at Princeton, NJ The Role The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations. This position is intended for a motivated professional seeking to grow into increasing levels of responsibility withi

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Full-time

$160,000 - $170,000

Senior Spectrum Engineer, Regulatory Affairs

Remote or Carlsbad, California

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Today

About us One team. Global challenges. Infinite opportunities. At Viasat, we're on a mission to deliver connections with the capacity to change the world. For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries around the globe communicate. We're looking for people who think big, act fearlessly, and create an inclusive environment that drives positive impact to join our team. What you'll do As a pivotal member of Viasat's global regulatory team, you

Full-time

USD 180,500.00 - 285,000.00 per year

CMC Regulatory Affairs Consultant

Wilmington, Delaware

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Yesterday

CMC Regulatory Affairs ConsultantJob Type: Contract 12 Months Location: Wilmington, DE Hybrid/Onsite Work Arrangement: 3 Days Onsite per Week Non-Negotiable Required QualificationsBachelor''s degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.Strong hands-on experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.Experience supporting large molecules and/or small molecules.Experience wit

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Third Party, Contract

Depends on Experience

Regulatory Affairs Specialist

Lake Forest, California

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7d ago

Job title: Regulatory Affairs Strategy Associate Location: Lake Forest, CA Duration: Permanent The Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for the regulatory strategy, ensuring local product registration and facilitating health registration approvals. WHAT YOULL BRING : Bachelors Degree or Equivalent years of directly related experience (or high school +7 yrs; Assoc.+5 yrs; M.S.+3 yrs) 7 Years of Relevant E

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Full-time, Third Party

Depends on Experience

Regulatory Affairs Specialist 4

Sunnyvale, California

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Today

Primary Function of Position The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. Essential Job Duties Provide regulatory guidance to product teams, develop regulatory plans, a

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Contract, Third Party

$60 - $60

Regulatory Affairs Data Coordinator

Remote or Irvine, California

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Today

Kelly Science and Clinical FSP is currently seeking an RA Data Coordinator for a long-term engagement in Irvine, CA with one of our Global clients. 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, 401K and a variety of other benefits to choose from. You may also be eli

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Contract

Regulatory Specialist

Des Plaines, Illinois

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Yesterday

Description: Key Responsibilities: 1. Provide strategic input and technical guidance on regulatory requirements to R&D project teams. 2. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. 3. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high quality submissions. 4. Monitor product-related activities for regulatory complia

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Contract

Depends on Experience

Regulatory Affairs Specialist Small Molecule

Remote

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2d ago

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Senior Pharma Submission SME

San Francisco, California

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30+d ago

Senior Pharma Submission SME for an onsite opportunity in the San Francisco Bay Area, CA. We''re looking for someone with: 10+ years in Regulatory Affairs, Operations, or Technical Writing within biotech/pharmaStrong expertise in IND, NDA, BLA, eCTD, and global regulatory submissionsExperience translating technical, clinical, and CMC content into compliant submission packagesProven leadership in submission strategy, process optimization, template standardization, and audit/compliance supportExce

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Contract, Third Party

Depends on Experience

Senior Compliance Analyst - Regulatory Exams

Dallas, Texas

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Today

Job Description The Sr. Compliance Analyst (Regulatory Exams) is responsible for supporting the network of Cetera Financial Group's broker/dealer and registered investment advisers throughout the examination process. The Regulatory Exam Manager is responsible for coordinating all aspects of firm and branch level examinations by state or federal agencies, as well as industry regulators such as FINRA. They monitor and track findings through remediation and closure and serve as the primary liaison

Full-time

USD 82,000.00 - 117,000.00 per year

Regulatory Specialist

Remote or Raynham, Massachusetts

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Today

Kelly Science and Clinical FSP is currently seeking a Regulatory Specialist for a long-term engagement with one of our Global MedTech clients. 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, 401K and a variety of other benefits to choose from. You may also be eligible

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Contract

Labeling Systems Analyst

Remote or New York, New York

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Today

RESPONSIBILITIES: Kforce has a client that is seeking a Labeling Systems Analyst in New York, NY. Summary: We are seeking an experienced Labeling Systems Analyst to support the maintenance and tracking of product labeling data across a global pharmaceutical environment. This role will partner with cross-functional stakeholders to ensure labeling information is accurate, compliant, and aligned with business needs throughout the product lifecycle. Key Responsibilities: * Labeling Systems Analyst

Contract

$75 - $85 hourly

Nuclear Licensing Engineer III

Camden, New Jersey

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Today

The Nuclear Licensing Engineer is responsible for applying engineering and nuclear regulatory knowledge and experience in support of developing power plant systems and programs in accordance with US licensing requirements. This requires a demonstrated understanding of 10 CFR Parts 50 and 52, along with associated regulatory and industry guidance. The Nuclear Licensing Engineer will be part of the SMR 300 Nuclear Licensing group, which is responsible for understanding, interpreting and informing

Full-time

USD 125,000.00 per year

Computer System Validation Engineer

Wilmington, Delaware

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Today

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time

Senior Architect

Tukwila, Washington

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Today

Job Description Job Title: Senior Architect Pay Rate: $60 - $70/hour. Location: Tukwila, WA Schedule: Full-time, Monday-Friday, 8:00 AM-5:00 PM Work Environment: 100% Onsite Employment Type: Contract (3-6 months) with potential for direct hire Start Date: Right Away Keywords: #TukwilaJobs; #SeniorArchitectjobs; #INDREG We provide a competitive pay and benefits package. This position is offering a pay range of $60 - $70/hr. however, Belcan considers several factors when extending an offer, includ

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Full-time

USD 60.00 - 70.00 per hour