Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
Improve clients' Regulatory Information Management processes.
Work collaboratively with diverse teams to drive business value.
Enhance efficiency and compliance for clients in a rapidly evolving landscape.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Their system identifies top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Provide senior strategic Regulatory CMC leadership across Antares’ portfolio.
Advise on CMC readiness for INDs and global CTAs, ensuring alignment with clinical development plans and corporate objectives.
Guide the integration of CMC regulatory considerations into early development, manufacturing, and supply decisions.
Antares Therapeutics is focused on bringing transformative oncology therapies to patients. They operate with cross-functional teams including Global Regulatory Affairs, Technical Operations, Quality, and Supply Chain to meet corporate objectives.
Managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
Ensuring that new products and documentation are compliant with applicable quality and regulatory requirements.
Serving as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, and post-clearance activities.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity.
Position and sell R&D, clinical, and regulatory solutions to decision makers.
Identify, qualify, and close new business opportunities using a consultative sales approach.
Expand existing accounts by identifying unmet needs and engaging cross-functional stakeholders.
Jobgether is a platform that helps connect job seekers with companies. They use an AI-powered matching process to ensure applications are reviewed quickly and objectively, sharing a shortlist of top candidates with hiring companies.
Lead the development and implementation of regulatory and quality assurance strategies.
Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Act as an internal SME (Subject Matter Expert) on regulatory requirements.
Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Provide medical expertise and leadership in clinical development strategies aligned with company objectives.
Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
Serve as medical monitor for clinical trials and ensure adherence to ICH GCP, patient safety, and data integrity.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of experience and global hubs in the U.S., France, and the U.K, they are committed to a culture of collaboration, excellence, and impact and empower every individual to be their true selves and grow alongside the company’s success.
Provide regulatory compliance risk assessment and consultation.
Assist financial services clients in strengthening their compliance management systems.
Conduct regulatory compliance testing for federal consumer compliance regulations.
Wipfli provides accounting and consulting services. Their people are the core of their business, and they focus on relationships while encouraging individuals to follow their own path.
Responsible for business growth with existing manufacturers.
Create, manage, and execute the company’s strategic plan.
Maintain and strengthen overall client relationships.
CareTria is dedicated to providing exceptional care, currently seeking passionate contributors to join their team. As an equal opportunity employer, they value integrity, teamwork, and results-oriented individuals.
Lead and coordinate regulatory projects from initiation through completion.
Schedule and facilitate project meetings to ensure progress and alignment with all stakeholders.
Develop and manage project plans using project management tools.
Navitus is an alternative to traditional pharmacy benefit manager (PBM) models. They are committed to removing cost from the drug supply chain to make medications more affordable. At Navitus, team members work in an environment that celebrates diversity, fosters creativity and encourages growth.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.