Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
Guide global labeling strategy, document development, and cross-functional regulatory teams.
Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.
A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.
The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.
Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Own clinical supply chain order fulfillment, including labeling, packaging, and distribution of trial products.
Build and lead Clinical Supply Chain, Planning, and Warehousing teams with full regulatory compliance.
Develop sourcing strategies and manage vendors to ensure cost-effective, uninterrupted supply.
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies for cancer patients. The company blends the pioneering spirit of an emergent biotech with global oncology expertise, fostering a collaborative multidisciplinary team where every member makes an immediate impact.
Lead daily care coordination operations, assign workloads, and manage caseloads to ensure timely service delivery.
Coach and develop team members through mentorship, feedback, performance reviews, and training.
Monitor performance metrics, resolve escalated issues, and collaborate with stakeholders to improve access to care.
A healthcare services organization that helps members navigate care, connect with providers, and manage transitions. It fosters a collaborative, accountable, and member-centered culture with a focus on quality and compliance.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Serve as a technical lead and device subject matter resource across the medical device total product life cycle.
Analyze premarket and postmarket submissions, evaluating safety, effectiveness, and benefit-risk determinations.
Develop SOPs, real-world evidence protocols, and risk standards grounded in FDA guidance while mentoring junior engineers.
ICA, Inc. is a rapidly growing government consulting firm providing innovative solutions in public health research, advanced data science, and strategic services. Our small but collaborative team prioritizes work-life balance and supports dynamic, highly skilled professionals.
Guide institutional compliance with state authorization regulations for distance education and physical presence.
Support professional licensure disclosures and coordinate determinations across U.S. jurisdictions.
Manage international authorization reviews and maintain compliance data for regulatory reporting.
UCLA is one of the nation's leading public research universities, known for academic excellence and public service. Its Compliance Office provides guidance and oversight across a large, complex institution to support ethical practices and compliance with laws and regulations.
Ensure marketing, educational, and communications materials comply with FDA, FTC, USP, and state pharmacy regulations.
Lead cross-functional content reviews and provide practical, risk-based compliance guidance to teams.
Develop compliance SOPs, training resources, and auditable documentation to support scalable content operations.
Strive Pharmacy is a personalized compounding pharmacy that creates custom medications tailored to individual patient needs. The company is a growing team focused on disrupting the pharmaceutical industry with a human-centered approach and a collaborative culture.
Oversee delegated audits related to UM, Credentialing, Claims, Enrollment, and Appeals processes to ensure compliance with payer contracts.
Educate staff, update policies and workflows, and act as a liaison between payers and local market leadership during audits.
Operationalize regulatory communications from governing bodies and document process changes for upstream and downstream teams.
Dignity Health Management Services offers integrated management and business services to healthcare providers, focusing on managed care administrative and clinical services to contain costs and improve quality. It is part of CommonSpirit Health, a large health system with a mission-driven culture centered on community and patient care.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.