Regulatory Affairs Strategist

Regulatory Affairs EngineerNevro Corp is seeking a highly skilled Regulatory Affairs Engineer to join our team. As a Regulatory Affairs Engineer, you'll be responsible for ensuring that our IT systems and processes comply with regulatory requirements, particularly in the FDA-regulated environment (GxP).You'll work closely with our development teams to...

Job Summary:Revolution Medicines is seeking a Senior Manager, Regulatory Affairs to provide regulatory advice and guidance to project teams.Key Responsibilities:Manage and coordinate Regulatory Affairs activities within and between departments.Obtain and maintain National Health Authority approvals for investigational products.Manage planning, preparation,...

Job Title: Regulatory Affairs Manager - Biologics ExpertAbout the Role:We are seeking a highly experienced Senior Manager, Regulatory Affairs III to join our team at ATR International.Job Description:Key Responsibilities:Preparation of quality sections for INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses...

Leadership Role in Preventative MedicineWe are seeking a seasoned Health Economics and Outcomes Research Strategist to spearhead our efforts in demonstrating the clinical and economic value of our cutting-edge whole-body MRI technology. This leadership role requires a strategic thinker who can craft, execute, and optimize comprehensive HEOR strategies while...

About Nuvig Therapeutics Inc.Nuvig Therapeutics, Inc. is a science-driven research and clinical development organization focused on transforming how we approach and treat inflammatory and autoimmune diseases. Our team is dedicated to advancing innovative therapies that improve treatment options for patients.

We are seeking an experienced Market Access Strategist to join our team at Arcellx. As a leading biotechnology company, we are committed to delivering innovative cell therapies that improve the lives of patients with cancer and other incurable diseases.Job DescriptionIn this role, you will be responsible for developing and executing market access strategies...

Role OverviewRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies. As a key member of the Commercial Team, the Regional Insights and Engagement Director will work closely with Key Opinion Leaders (KOLs) at select institutions and accounts within the defined geography.The OpportunityThe Regional...

About PrenuvoPrenuvo is a pioneering healthcare company on a mission to revolutionize proactive health care. Our cutting-edge whole-body scan technology is fast, safe, and non-invasive, with a unique integrated stack of optimized hardware, software, and AI. With clinics across North America and internationally, we're leading the charge against 'we caught it...

Achieve Success with Nuvig Therapeutics Inc.We offer a competitive compensation package, including base salary and performance bonus, as well as stock option packages and comprehensive benefits.About the RoleThe Director of Global Compliance will oversee the development and implementation of global regulatory strategies, ensuring alignment with Health...

About Karius, Inc.Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. Our platform delivers unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying over 1,000 pathogens directly from blood.Job SummaryThe Senior Clinical Development...

Jasper Therapeutics is a pioneering biotechnology company dedicated to developing innovative treatments for chronic mast and stem cell diseases. Our flagship product, briquilimab, has shown remarkable efficacy and safety in clinical trials, offering new hope for patients with conditions such as CSU, CIndU, and asthma.The ideal candidate will play a crucial...

Company Overview: Adverum Biotechnologies, Inc. is a clinical-stage gene therapy company focused on unmet medical needs in ophthalmology and rare diseases. Our expertise lies in clinical development, novel vector discovery, and in-house manufacturing.About the Role: We are seeking a highly skilled Director of Upstream Gene Therapy Development to join our...

Job Overview:Peninsula Clean Energy, a pioneering community choice energy program, seeks a seasoned policy professional to lead its legislative efforts in California and the nation. This role is instrumental in shaping the organization's stance on clean energy policies and driving its mission to reduce greenhouse gas emissions.Key Responsibilities:Develop...

Job SummaryThe Director of Human Resources will lead the planning, execution, and development of human resources strategies to support Exceptional Children's Foundation's mission, goals, and talent strategy. This role oversees the administration of human resource programs, ensuring compliance with federal and state employment laws and...

Job Title:Residential Treatment Center Operations ManagerAbout the Role:We are seeking an experienced and skilled Residential Treatment Center Operations Manager to join our team at Beloved Ones. As a key member of our leadership team, you will be responsible for ensuring the smooth operation of our residential treatment center, providing exceptional care...

Job DescriptionExecutive Director, Analytical Development – PivotalThe Executive Director of Analytical Development will spearhead the analytical development encompassing method development, qualification, and molecule characterization for all biologics programs during the Pivotal and Commercial phases. This individual will play an instrumental role in...

Overview:Rose International seeks a seasoned Development Project Manager to oversee projects of moderate complexity, driving cross-functional collaboration and ensuring timely delivery. This role requires strong project management skills, industry knowledge, and the ability to coach team members.About the Role:This position is responsible for managing task...

The Opportunity:The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements,...

Why Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with...

Why Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with...

Why Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with...

Why Nuvig Be a part of a potential game-changer for patients with autoimmune disease!  Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases.  Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment...

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...

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...

About Urban Affairs AssociationAt the Urban Affairs Association, we are committed to addressing real property issues that impact disadvantaged communities. Our team is dedicated to developing legal reform and policy proposals to address critical land and housing issues at the local, state, and federal level.

The Opportunity:The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements,...

Job DescriptionAs a Regulatory Affairs Specialist at Axiom Software Solutions Limited, you will be responsible for ensuring compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.Key Responsibilities:Represent Regulatory Affairs on cross-functional project teams.Provide technical expertise to cross-functional teams...

About the Role:We are seeking a highly qualified Regulatory Affairs Director to lead our compliance efforts at Futu US, Inc.Key Responsibilities:Provide strategic guidance on regulatory matters to ensure compliance with applicable laws and regulations.Develop and implement effective compliance programs to mitigate risks and maintain a strong...

**Job Title:** Regulatory Affairs Coordinator**Company Overview:** Red River Science & Technology is a leading provider of training, logistics, and technology solutions. We strive for excellence in meeting our customers' needs both CONUS and OCONUS.**Job Description:**We are seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a...

Director of Regulatory AffairsAnnual Compensation: $105,000 - $130,000.About the RoleWe are looking for a highly skilled Director of Regulatory Affairs to join our team at Louisiana Downs Investment Company LLC. This individual will be responsible for overseeing the development and implementation of our regulatory compliance program, ensuring that we...

The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be...

Job DescriptionJob DescriptionWe are seeking a Senior Manager, Regulatory Affairs III for a very important client. RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics...

Job Summary:We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. In this role, you will be responsible for assisting the Regulatory Team with maintenance and registration of new products and state wholesaler licenses as required by regulatory agencies.About the Role:Provide regulatory support to all functional...

Axiom Software Solutions Limited is looking for an experienced Regulatory Support professional to support our regulatory operations. The ideal candidate will have a solid understanding of regulatory affairs and experience working with Veeva RIM Submission/Archive, Publishing etc.The estimated salary for this position is $140,000 - $200,000 per year,...

**About Us:**Louisiana Downs Investment Company LLC is committed to providing exceptional gaming experiences for our patrons. We are seeking a highly skilled Regulatory Affairs Specialist to join our team and play a critical role in ensuring compliance with relevant laws and regulations.The estimated salary for this role is $90,000 - $130,000 per year, based...

Empower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...

Job Title: Regulatory Affairs Associate - Quality Control We are seeking a highly organized and detail-oriented Regulatory Affairs Associate to join our Quality Assurance team at RK Pharma Inc. and support our efforts in ensuring product quality and regulatory compliance. Main Responsibilities:Assist in reviewing and approving Quality Control...