regulatory affairs Jobs

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Head of Global Regulatory Affairs Labeling

Takeda pharmaceutical

Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies fo

Executive Director, Regulatory Affairs, Labeling

Gilead Sciences, Inc.

Remote

Full-time

Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team pl

Director, Global Regulatory Affairs, Precision Medicine

Gilead Sciences, Inc.

Parsippany-Troy Hills, New Jersey, USA

Full-time

Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team pl

Sr Director, CMC Regulatory Affairs -Small Molecules

Gilead Sciences, Inc.

Foster City, California, USA

Full-time

Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team pl

Sr Director, CMC Regulatory Affairs -Small Molecules

Gilead Sciences, Inc.

Foster City, California, USA

Full-time

Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team pl

Sr. Principal, Regulatory Affairs Specialist, Core and NGS

Danaher Corporation

Coralville, Iowa, USA

Full-time

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global t

Associate Director, Regulatory Affairs Advertising and Promotion

Gilead Sciences, Inc.

Parsippany-Troy Hills, New Jersey, USA

Full-time

Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team pl

Senior Director, CMC Regulatory Affairs - Biologics Project Lead

Gilead Sciences, Inc.

Foster City, California, USA

Full-time

Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team pl

Director, Global Regulatory Affairs & Clinical Safety (GRACS), Global Process Lead

Merck & Company Inc

Rahway, New Jersey, USA

Full-time

Job Description The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing end-to-end processes and ensuring consistency and standardization across regions and functional areas.The role of the GPL involves developing and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The

Quality Lead Specialist - Regulatory Affairs

GE Healthcare

Waukesha, Wisconsin, USA

Full-time

Job Description Summary Provides regulatory strategy and direction to the Magnetic Resonance business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. This position will be supporting the Magnetic Resonance Premium segment. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how

Senior Specialist, Standards & Execution - Global Regulatory Affairs & Clinical Safety (GRACS)

Merck & Company Inc

Rahway, New Jersey, USA

Full-time

Job Description The Senior Specialist, Global Regulatory Affairs and Clinical Safety (GRACS) Standards & Execution is a member of Business Continuity, Standards & Training (BCST). This role is critical to the success of the GRACS end to end business process operating model. Under the guidance of the Director, Standards & Execution Lead, the Standards & Execution Sr. Specialist is responsible for the planning and execution of operational activities related to GRACS process execution and documen

Sr. Manager, Regulatory Affairs, Core and NGS

Danaher Corporation

Boulder, Colorado, USA

Full-time

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global t

Senior Regulatory Affairs Specialist

Philips North America

Plymouth, Minnesota, USA

Full-time

Job Title Senior Regulatory Affairs Specialist Job Description Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all. In this role you have the opportunity to You will prepare comprehensive regulatory strategies and filings for both new and legacy devices including significant device changes. You will clearly co

Senior Director, Global Regulatory Affairs & Clinical Safety (GRACS)Global Process Model Lead

Merck & Company Inc

Rahway, New Jersey, USA

Full-time

Job Description The GRACS Global Process Model Lead is primarily accountable and responsible for the overall governance and leadership of the GRACS Global Business Process Model, including managerial responsibilities for the GRACS Global Process Leads, leadership for the Global Process Lead Network, as well as defining the strategy and approach to optimize end-to-end processes and ensure consistency and standardization across regions and functional areas. This is accomplished through the utiliz

Sr. Manager- Regulatory Affairs

Philips North America

Gainesville, Florida, USA

Full-time

Job Title Sr. Manager- Regulatory Affairs Job Description The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products , ensuring and maintaining global accurate regulatory strategy and market access , directly impacting the lives of patients around the world. Your role: Leading project teams for end-to-end regulatory affairs input and deliverables for new produ

Manager, Global Regulatory Affairs CMC

Sanofi U.S.

Bridgewater, New Jersey, USA

Full-time

Job title: Manager, Global Regulatory Affairs CMC Location: Bridgewater, NJ or Cambridge, MA About the job: The Manager, Global Regulatory Affairs CMC is accountable for global strategic management of a portfolio of development projects and/or marketed products within GRA CMC & Devices Departments (Small Molecules Marketed, Small Molecules Development, Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, inc

Regulatory Affairs Manager

Danaher Corporation

West Sacramento, California, USA

Full-time

Wondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build

Senior Regulatory Affairs Specialist

Philips North America

Bothell, Washington, USA

Full-time

Job Title Senior Regulatory Affairs Specialist Job Description Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all. In this role you have the opportunity to Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU s

Staff Regulatory Affairs Specialist, Infusion - Remote

BD Diagnostics - TriPath

Remote or California, USA

Full-time

Job Description Summary As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management of submissions, development and review of procedures and systems design to support regulatory processes, and address global regulatory requirements and business objectives. Job Description We are the makers of possible BD i

Manager, Regulatory Affairs North America

Johnson & Johnson

Spring House, Pennsylvania, USA

Full-time

Description Johnson & Johnson is recruiting for Manager, Regulatory Affairs North America. The position can be located in Spring House, PA. 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 smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across