Regulatory Affairs Specialist Jobs

1 - 20 of 4,345 Jobs

Regulatory Affairs Specialist, Cell & Gene TherapyJob Title - Regulatory Affairs Specialist, Cell & Gene Therapy

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

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Remote

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for a remote based opportunity to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents. Support document workf

Regulatory Affairs Specialist, Cell & Gene TherapyJob Title - Regulatory Affairs Specialist, Cell & Gene Therapy

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

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Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents.

Regulatory Affairs Specialist IIIJob Title - Regulatory Affairs Specialist III

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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Asheville, North Carolina, USA

Full-time

Job Description Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a st

Regulatory Affairs SpecialistJob Title - Regulatory Affairs Specialist

Ledgent TechnologyCompany Name - Ledgent Technology

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Irvine, California, USA

Contract

Summary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Key Responsibilities: * Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in c

Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.Job Title - Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.

Johnson & JohnsonCompany Name - Johnson & Johnson

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Cincinnati, Ohio, USA

Full-time

Description Robotics & Digital Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Specialist . The preferred location for this role is within a commutable distance of Cincinnati, OH however candidates within commutable distance of Santa Clara, CA or Raritan, NJ will also be considered . This role will work a Flex/Hybrid schedule with 3 days per week on-site. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our

Sr. Regulatory Operations SpecialistJob Title - Sr. Regulatory Operations Specialist

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

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Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers. Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and

Senior Regulatory Affairs Program LeadJob Title - Senior Regulatory Affairs Program Lead

Johnson & JohnsonCompany Name - Johnson & Johnson

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Irvine, California, USA

Full-time

Description The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Tech sector within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Program Lead for International Registration, as part of the Regulatory Affairs Global Execution team, located in Irvine, CA. 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 sma

CMC 2 Regulatory affairsJob Title - CMC 2 Regulatory affairs

Hectadata LLCCompany Name - Hectadata LLC

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Jersey City, New Jersey, USA

Contract, Third Party

Greetings from Hectadata, LLC. We are hiring for the position of CMC 2 Regulatory affairs Please find the below Job Description. If you are interested in this position, kindly submit your applications via Dice. Job Title: CMC 2 Regulatory affairs Location: JFK Parkway, NJ Job Description: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with

Senior Regulatory AffairsJob Title - Senior Regulatory Affairs

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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High Point, North Carolina, USA

Full-time

Job Description When you join us at Thermo Fisher Scientific, you'll be part of a hard-working and driven team that shares your passion for exploration and discovery. With revenues of approximately $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Ranked #69 on the 2023 Fortune 500 list, you'll discover endless opportunities to grow a rewarding career as part of the world leader in servin

Regulatory Affairs Manager - Structural Heart (on-site)Job Title - Regulatory Affairs Manager - Structural Heart (on-site)

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Saint Paul, Minnesota, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future

Regulatory Affairs AssociateJob Title - Regulatory Affairs Associate

Apex SystemsCompany Name - Apex Systems

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Mountain View, California, USA

Full-time

Job#: 2027155 Job Description: Client: IRIDEX Position: Regulatory Affairs Associate Location: Mountain View, CA Estimated Duration: The client approximates that this project may last up to 5 months. However, there is no guarantee of employment for any length of time. Pay Rate Range: $35 - $45/hr IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, Health Cana

Regulatory Affairs ConsultantJob Title - Regulatory Affairs Consultant

Stellar Consulting SolutionsCompany Name - Stellar Consulting Solutions

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Arkansas, USA

Full-time

Stellar Consulting Solutions is a boutique business & technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects of any scale. We help forward thinking clients to solve specific problems by understanding their needs and align talent that can move fluidly to match skill supply and demand on a real-time basis. Stellar Consulting has a unique combination of technical and digital skills to recruit, engage, and

Regulatory Affairs Manager - ElectrophysiologyJob Title - Regulatory Affairs Manager - Electrophysiology

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Plymouth, Minnesota, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo

Manager Regulatory AffairsJob Title - Manager Regulatory Affairs

Abbott LaboratoriesCompany Name - Abbott Laboratories

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Des Plaines, Illinois, USA

Full-time

Regulatory & Medical Affairs - Project ManagerJob Title - Regulatory & Medical Affairs - Project Manager

Sunrise Systems, Inc.Company Name - Sunrise Systems, Inc.

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Lawrence Township, New Jersey, USA

Contract

Job Title: Regulatory & Medical Affairs - Project Manager Job ID: 24-01565 Location: Lawrence Township, NJ, 08648 Duration: 06 Months contract on W2 Onsite full time at Princeton Pike. Innovation and Digital Health, Project Manager - Digital Optimization Initiatives Position Summary The Innovation Lab team partners with R&D stakeholders to design and deliver innovative analytics solutions that help them make better decisions, reduce costs and/or drive efficiencies. Our diverse analytics team of

Regulatory & Medical Affairs - Project ManagerJob Title - Regulatory & Medical Affairs - Project Manager

Net2Source Inc.Company Name - Net2Source Inc.

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Lawrence Township, New Jersey, USA

Contract

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.Job Description: Onsite full time at Princet

Regulatory Specialist (US)Job Title - Regulatory Specialist (US)

Dexian DISYSCompany Name - Dexian DISYS

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Erlanger, Kentucky, USA

Contract

Job Title - Regulatory Specialist Duration -10+ Months Location - Erlanger KY 41018 (Hybrid 3- Days Onsite,2 days Remote) Roles and Responsibilities: Regulatory Specialist to support the business /operations productivity to communicate with vendors technical regulatory inquiries, documentation needs and data maintenance and interpretation. A working knowledge of FDA food regulations and relevant product design status such as GM\BE, Allergens, GRAS, Vegan, Natural, Kosher, Organic, Halal, Nutr

Regulatory Affairs Senior ManagerJob Title - Regulatory Affairs Senior Manager

Software Guidance & AssistanceCompany Name - Software Guidance & Assistance

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Hawthorne, New York, USA

Full-time

Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY. Responsibilities: US Agent for all Firm's products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications Lead, guide and t

RN-Accreditation, Regulatory, and Licensing Specialist V Home Health Exp. Required (KFH/HP)Job Title - RN-Accreditation, Regulatory, and Licensing Specialist V Home Health Exp. Required (KFH/HP)

Kaiser PermanenteCompany Name - Kaiser Permanente

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Pasadena, California, USA

Full-time

Description: Job Summary: Conducts regulatory audits and surveys by consulting on the interpretation and interaction of current regulatory policies and requirements in preparation for surveys. Organizes, coordinates, and conducts facilitation of on-site visits and evaluations. Performs site visits in accordance with criteria to ensure survey readiness. Ensures completion of surveys, independently. Conducts routine audits and mock surveys to aid in preparedness, tracking, trending, and facilita

Regulatory Specialist (Energy Markets)Job Title - Regulatory Specialist (Energy Markets)

ApexonCompany Name - Apexon

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Jollyville, Texas, USA

Third Party, Contract

Skills: Electricity marketsRegulationsJob description: Over 10 Years of experience.Experience in working with the energy sector on market principles and structures.Experience/knowledge of energy and power industry policies & regulations.Ability to present to high level executives & Leaders.knowledge of U.S. electricity markets is Must.