regulatory affairs Jobs

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Senior Regulatory Affairs Specialist

Sunrise Systems, Inc.

Chaska, Minnesota, USA

Contract

Our client, a leading medical devices manufacturing company, is looking for a Senior Regulatory Affairs Specialist. This is for an initial duration of 18 months and is located in Chaska, MN. Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship) 3 must haves: Experience with design changes, demonstrated RA leadership on high visibility core team, IVDR or EMDR experience Job Description: The Senior Specialist Regulatory Affairs is an individual contributor and subject

Manager Regulatory Affairs

Sureminds Solutions

Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Manager Regulatory Affairs, Structured Product Labelling (SPL) for USA market Remote role Max rate is $55/hr on c2C Job Description: Manager Regulatory Affairs, Structured Product Labelling (SPL) for USA market In this role Candidate should have experience in regulatory affairs while essential exposure to Structured Product Labelling (SPL) for assigned products and also need to have good knowledge of labelling requirements for USA market. In de

Assistant Director Regulatory Affairs

Zachary Piper Solutions, LLC

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 gain

Associate Director of Regulatory Affairs

Zachary Piper Solutions, LLC

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

Associate Director of Regulatory Affairs

Zachary Piper Solutions, LLC

Eden Prairie, Minnesota, USA

Full-time

Piper Companies is currently seeking an Associate Director of Regulatory Affairs to support IND submissions and regulatory strategy for a groundbreaking biotechnology company in Eden Prairie, MN (Relocation Assistance Available) Responsibilities for the Associate Director of Regulatory Affairs Serve as the regulatory lead for IND submissions and ongoing regulatory strategyAuthor core IND content, collaborating with cross-functional teams for technical inputSubmit regulatory documentsManage and m

Associate Director of Regulatory Affairs

Zachary Piper Solutions, LLC

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 Manager

Zachary Piper Solutions, LLC

Raleigh, North Carolina, 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 Manager

Zachary Piper Solutions, LLC

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 and Compliance Analyst (Medicare)

CalOptima

Orange, California, USA

Full-time

Regulatory Affairs and Compliance Analyst (Medicare) CalOptima CalOptima Health is seeking a highly motivated Regulatory Affairs and Compliance Analyst (Medicare) to join our team. The Regulatory Affairs and Compliance Analyst (Medicare) will coordinate and maintain CalOptima Health's relationships with regulatory agencies, including but not limited to supporting, enhancing and strengthening CalOptima Health's policy infrastructure, platform and strategy at the state and federal level. The incum

Associate Director, Global Regulatory Affairs - Global Labeling Strategy

Sanofi

Cambridge, Massachusetts, USA

Full-time

Job Title: Associate Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development, m

Associate Director, Global Regulatory Affairs - Global Labeling Strategy

Sanofi

Morristown, New Jersey, USA

Full-time

Job Title: Associate Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development, m

Director, Global Regulatory Affairs - Global Labeling Strategy

Sanofi

Cambridge, Massachusetts, USA

Full-time

Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and implementation of

Director, Global Regulatory Affairs - Global Labeling Strategy

Sanofi

Morristown, New Jersey, USA

Full-time

Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and implementation of

Structured Product Labeling(SPL), Regulatory Affairs--New Jersey(Remote)

HUMAC INC.

Remote

Contract

Hello, I Hope you are doing well. This is Surya from Humac Inc., Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you. Role: Structured Product Labeling(SPL), Regulatory Affairs Location: New Jersey(Remote) Duration of the project: 12+ Months Contract Responsibilities Review of SPLs content labelling Submission of SPLs content labelling Monitoring of recent updates in SPL Escalate, notify and

Regulatory Affairs Manager with Structured Product Labelling (SPL) Experience

Adam Information Technologies LLC

Chicago, Illinois, USA

Contract

We have a below position for Regulatory Affairs Manager with Structured Product Labelling (SPL) for long term duration. Please find the JD below Candidate should have experience in regulatory affairs while essential exposure to Structured Product Labelling (SPL) for assigned products and also need to have good knowledge of labelling requirements Responsibilities Review of SPLs content labellingSubmission of SPLs content labellingMonitoring of recent updates in SPLEscalate, notify and resolve an

Regulatory Affairs Manager

Sureminds Solutions

Remote

Full-time

In this role Candidate should have experience in regulatory affairs while essential exposure to Structured Product Labelling (SPL) for assigned products and also need to have good knowledge of labelling requirements for USA market. In depth working knowledge of SPL review and submissions. Responsibilities Review of SPLs content labelling Submission of SPLs content labelling Monitoring of recent updates in SPL Escalate, notify and resolve any issues that may impact final submission. End to end re

Regulatory Affairs Specialist- 100% remote in FL

ConsultNet, LLC

Remote or Florida, USA

Full-time

Regulatory Affairs Specialist 100% Remote from anywhere in Florida 6+ month contract to hire $38.50- $52.00 an hour ($80k- $110k salary upon conversion) Immediate hire with growing company. The Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presente

Regulatory Affairs Specialist China NMPA (Ultrasound Imaging)

Comrise

Remote or Issaquah, Washington, USA

Contract

Job DescriptionPosition Title: Regulatory Affairs Specialist China NMPA (Ultrasound Imaging)Location: Hybrid/Remote Issaquah, WA preferredDuration: 3 6 Month ContractPay Rate: Up to $60/hourIndustry: Medical Devices Ultrasound Imaging Position Overview:We are seeking a contract Regulatory Affairs Specialist with proven experience supporting China NMPA registration for medical devices, ideally in the ultrasound imaging space. This role will focus on preparing and compiling regulatory submissions

Regulatory Affairs Manager

LMI Government Consulting (Logistics Management In

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

Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)

Sanofi

Morristown, New Jersey, USA

Full-time

Job DescriptionJob Title: Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) Location: Cambridge, MA or Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Pr