Senior Regulatory Affairs Leader

Senior Director of Regulatory AffairsMedical Robotics: Cardiovascular: Innovative Start-upOversee all FDA Pre-Market Approval submission processesSupervise post-market modifications and global registrationsEngage with FDA to ensure successful PMA submission and endorsementThe Mullings Group is on the lookout for a Senior Director of Regulatory Affairs. This...

About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...

Position Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...

Position Overview:Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive,...

Job OverviewAbout Radionetics OncologyRadionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics and is backed...

Position OverviewAbout Radionetics OncologyRadionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics and is...

Position OverviewAbout Radionetics OncologyRadionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics,...

Job SummaryStryker Group, a leading medical technology company, is seeking a highly skilled Regulatory Affairs Director to join our Endoscopy business unit. As a key strategist, you will be responsible for developing and delivering regulatory strategies to bring Stryker's best-in-class Visualization products to market in the United States, Canada, and...

R&D Partners is looking for a Senior Regulatory Affairs Specialist III. Key Responsibilities: Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain submissions and product...

About Danaher Corporation: Danaher Corporation is a global leader in the life sciences and diagnostics sectors, committed to innovation and excellence in our products and services.Position Overview: We are seeking a Senior Specialist in Regulatory Affairs for Core and NGS Technologies. This role is integral to our Quality Assurance and Regulatory Affairs...

About the PositionThe Executive Director, Clinical Regulatory Affairs will lead the development and implementation of global regulatory strategies for clinical development programs to secure and maintain market access for product(s) in line with business objectives. This role will provide strategic regulatory oversight for designated projects, ensuring that...

Position Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...

Senior Regulatory Affairs SpecialistGenalyte, Inc., a frontrunner in cutting-edge diagnostic solutions, is seeking a highly qualified and driven Senior Regulatory Affairs Specialist to become part of their innovative team. In this position, you will be tasked with navigating intricate regulatory frameworks to guarantee adherence to all standards and...

Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a global team dedicated to transforming the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our outstanding workforce is crucial to our achievements. We are a committed group focused on addressing the specific needs of patients with...

Job SummaryWe are seeking a highly experienced Regulatory Affairs Director or Senior Regulatory Affairs Director to join our team at Kura Oncology. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with governing laws, regulations, and internal policies and procedures.Key ResponsibilitiesEnsure U.S....

Position Summary:Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated regulatory...

Job Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...

Join Our Team as a Regulatory Affairs ManagerWe are seeking a skilled Regulatory Affairs Manager to become part of our client's team and have a significant role in introducing new products to the market. As the Regulatory Affairs Manager, you will be responsible for leading the regulatory strategy and overseeing submissions for new product releases within...

R&D Partners is in search of a Senior Regulatory Affairs Consultant. Key Responsibilities: Support ongoing marketed products by reviewing engineering modifications, promotional materials, labeling, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain product technical files while overseeing compliance...

Position OverviewGenalyte, Inc., a pioneer in innovative diagnostic solutions, is in search of a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your knowledge to navigate intricate regulatory frameworks, ensuring our revolutionary products adhere to all...