Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.
Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.
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.
Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.
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.
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.
Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.
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.
Lead planning, execution, and integrated governance for Future of Medicine initiatives across Clinical Conduct, Quality, Technology, and Operations.
Translate clinical, operational, quality, and program needs into scalable workflows, requirements, SOPs, and training.
Drive readiness, change planning, and sustained adoption of new program requirements and technology capabilities.
Care Access brings world-class clinical research and health services to communities facing barriers to care through hundreds of research locations, mobile clinics, and global clinicians. The company values an inclusive culture where diverse backgrounds are welcomed and people are at the heart of medical progress.
Own CMC end-to-end for a trispecific TCE program from discovery handoff to IND, including timeline, budget, and quality.
Run competitive CDMO selection across US, European and Chinese vendors, then negotiate and manage the chosen partner.
Author Module 3, build the pre-IND briefing package, and represent CMC in agency meetings.
Shennon Biotechnologies is developing precision immunotherapies for solid tumors using an integrated platform that profiles millions of single-cell interactions in a single experiment. The company values collaboration, ownership and authenticity and is based in San Francisco.
Implement and optimize REMS and specialty pharmacy workflows for COMP360 in the U.S.
Manage vendor relationships, compliance metrics, and cross-functional collaboration.
Support launch readiness, audits, and continuous process improvement.
Compass Pathways is a biotech developing COMP360 psilocybin for treatment-resistant depression and PTSD, with FDA Breakthrough Therapy designation. Headquartered in London with a U.S. office in New Jersey, it focuses on patient-centered mental health innovation.