Job DescriptionABOUT US:
At Vitrafy Life Sciences, we’re not just part of the biotech industry, we’re redefining it by improving the quality of healthcare treatments by providing effective cryopreservation solutions. Our breakthrough cryopreservation technologies could create new global standards in the way biological materials are preserved, transported, and delivered, ultimately helping pres...
Job DescriptionAbout Slate
Slate Medicines is a clinical-stage biotechnology company committed to advancing innovative new therapies that may broaden the treatment paradigm and potentially improve outcomes for people with migraine and other headache disorders. Slate is advancing a portfolio of potentially best-in-class therapeutics, led by SLTE-1009, a clinical-stage anti-PACAP/VIP monoclonal antib...
Job DescriptionPosition Overview
The Quality & Regulatory Affairs Manager is responsible for ensuring organizational compliance with applicable regulatory requirements while leading and improving customer-facing quality processes. This position plays a critical role in maintaining product and quality compliance, supporting regulatory submissions, managing customer quality concerns and complaints, a...
Job DescriptionPosition Summary
Our Startup Client is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies.
This executive will have overall responsibility for establishing and maintaining a phase-appropriate Quality Management System, providingstrategi...
Job DescriptionCompany Description
Mazza Healthcare is a healthcare solutions company with strong expertise in global sourcing and private label portfolio development. We advance the cost-effectiveness and quality of healthcare products while remaining committed to patient safety. Mazza Healthcare has experienced rapid growth over the past several years and is currently seeking a Specialist, Qualit...
Job DescriptionMCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams com...
Job DescriptionVice President, Regulatory Affairs
Position Overview
The Vice President, Regulatory Affairs will provide strategic and operational leadership for the Regulatory Affairs function supporting a global medical device and diagnostics business. This executive will be responsible for developing and executing regulatory strategies that support product innovation, commercialization, lifecyc...
Job Description
About the Company
Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.
About the Role
The Regulatory Affairs Manager is responsible for supporting the development and e...
Job DescriptionRegulatory Affairs Specialist
Job Type: Full time - Permanent
Location: Madison, New Jersey (On-site)
A commercial-stage transplant technology company, part of a global medtech group, is changing how donor organs are preserved and assessed before transplant. Their flagship platform is already used in thousands of procedures across the US, Europe, Canada and Australia, and they are g...
Job DescriptionWe’re Hiring: Regulatory Affairs & Compliance Manager
? Indianapolis, IN | ? $90,000–$95,000
Kelly Science & Clinical is seeking a Regulatory Affairs & Compliance Manager to lead domestic and international regulatory compliance for a cosmetic manufacturer in Indianapolis.
This is a key role responsible for ensuring regulatory compliance while partnering across the organization t...
Job DescriptionThe group exists to provide professional consulting, implementation and project management services to clients to enable the conduct of clinical trials and associated regulatory activities. The group is also responsible to internal customers to inform the design, development, sale, support and implementation of clinical research software as complete solutions or as part of solutions....
Job DescriptionQMS Consulting seeks a Regulatory Specialist with direct experience drafting federal rules for the
a federal agriculture agency. The specialist will serve as a rulemaking subject matter lead for up to three proposed-rule efforts. Working with QMS analysts and federal agency staff, this person will turn public submissions into accurate, traceable issue summaries and writing support fo...
Job DescriptionSenior Director, Regulatory Affairs - Hybrid NYC Area
Key Responsibilities
Develop and execute regulatory strategies supporting clinical development and future product approvals.
Lead and support preparation and submission of regulatory filings, including INDs, NDAs, and international submissions.
Provide regulatory guidance to cross-functional teams throughout the product devel...
Job DescriptionRetained Search | Hybrid Position
I am conducting a retained search for a Vice President, Global Regulatory & Clinical Strategy on behalf of a commercial-stage biotech with a growing pipeline spanning small molecules, biologics, and gene therapy.
This is a highly visible global leadership role reporting directly to the SVP, Regulatory Affairs, with regular executive exposure and a ...
Job DescriptionSenior Director, Regulatory Affairs (fully on-site in San Diego)
Summary
Our client is a well-funded, growth-stage medical technology company developing a Class III active implantable platform at the intersection of healthcare and advanced engineering. This role serves as the senior regulatory leader for the company's San Diego operations, providing strategic and operational oversig...
Job DescriptionResponsibilities
Maintain regulatory binders and essential documents for active oncology trials after study activation
Prepare and submit IRB continuing reviews, amendments, safety reports, and protocol deviations
Manage sponsor and FDA correspondence, including IND safety reports and annual reports
Track regulatory timelines for assigned studies and ensure compliance with FDA, ...
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