Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.
Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.
Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Provide expert regulatory guidance to pharmaceutical and biotech C-suite executives, shaping critical development and portfolio decisions.
Generate new business and meet sales targets while leading complex regulatory engagements and mentoring team members.
Represent Lumanity at industry forums and contribute to practice innovation and thought leadership.
Lumanity is a global strategic partner dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. The company brings together strategy, evidence, engagement, and technology to engineer breakthrough value for biopharma clients.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
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.
Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.
Develop and operationalize QA frameworks for AI tools, including testing protocols, evaluation rubrics, and monitoring systems.
Conduct pre- and post-production evaluation of AI outputs for clinical safety, accuracy, bias, and regulatory alignment.
Analyze QA findings and trends to generate actionable Clinical AI QA reporting and drive improvements.
BetterHelp removes barriers to therapy, making mental health care accessible to everyone. As the world's largest online therapy service with over 30,000 licensed therapists, we deeply invest in our team's well-being and professional development.