Specialist, Regulatory Affairs

We are currently seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be pivotal in ensuring compliance with regulatory requirements for our pharmaceutical and cosmetic products. Your responsibilities will include preparing and submitting regulatory documents, coordinating...

We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...

About Nevro: Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from...

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work...

We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...

About Nevro:Nevro (NYSE:NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating...

Summary: U.S. Branded & Generic Product Portfolios The Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of labeling content along with the review...

Job Description Organon is hiring Senior Specialist Regulatory Affairs. The Senior Specialist will be responsible for all RA submission requirements and PV activities for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission...

Pay Rate- to Onsite - Yes Regulatory Affairs Labeling Associate Level - I is needed to support Client' business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Support labeling review process with a Quality Assurance and data integrity mindset. Apply...

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into...

With our strong investment in research and development and our culture of continuous improvement, Hexcel is the industry leader in the manufacturing of advance composite materials, including carbon fiber, woven reinforcements, resins, prepregs, honeycombs and additive manufactured parts. We invite you to join the Hexcel team at various manufacturing sites,...

With our strong investment in research and development and our culture of continuous improvement, Hexcel is the industry leader in the manufacturing of advance composite materials, including carbon fiber, woven reinforcements, resins, prepregs, honeycombs and additive manufactured parts. We invite you to join the Hexcel team at various manufacturing sites,...

Responsibilities: The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below. Support Product Development & Registration: Provides strategic input and...

Overview We are looking for a Regulatory Affairs Associate II to join our Regulatory Affairs team at Myriad Genetics. This position has the ability to be hybrid in Salt Lake City, UT or remote across the country. Written communication is critical to this position; a cover letter for this position is highly recommended. The Regulatory Affairs Associate...

Senior Director, Regulatory Affairs (Generalist)Hybrid Role - 3 Days in Menlo Park, CAMeet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC...

Responsibilities: The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below. Support Product Development & Registration: Provides strategic input and...

Senior Regulatory Affairs Specialist - Remote (Temporary) page is loaded Senior Regulatory Affairs Specialist - Remote (Temporary) Apply locations South Jordan, UT Pearland, TX time type Full time posted on Posted 3 Days Ago job requisition id JR108689 Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical...

Job DescriptionThe Position The Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing and Controls (CMC) strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and...

POSTION SUMMARYThe Director, Regulatory Affairs Global Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. The Director will partner with all Regulatory Affairs functions, Medical...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment...