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.
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.
Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.
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.
Develop and implement global regulatory strategies for oncology programs from early development through post-marketing.
Lead preparation and submission of INDs, NDAs, and other regulatory filings to ensure compliance and quality.
Provide strategic regulatory guidance and cross-functional collaboration to drive program success.
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines for cancer, neurologic and autoimmune disease. They cultivate an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Drives complex FDA regulatory submissions for biologic programs from Phase 1 through marketing applications.
Builds and owns quality systems including CAPA, nonconformance reports, change control, and SOP management.
Provides regulatory guidance and coordinates risk assessments to ensure rapid product approvals.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Provide senior-level regulatory CMC expertise for small-molecule products, focusing on Chemistry, Manufacturing, and Controls (CMC) compliance.
Interpret North American regulatory guidelines and support product lifecycle activities, including reporting and surveillance.
Collaborate with cross-functional teams in an international environment, applying drug development knowledge to complex regulatory needs.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses technology to ensure fair and efficient application reviews, while the partner company this role is listed for is a global life sciences consulting firm with international experts and a collaborative culture.
Lead global regulatory strategy for first-in-class small-molecule medicines.
Drive development of submissions and health authority interactions worldwide.
Provide regulatory expertise and mentorship to cross-functional teams.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than the industry standard. They recently raised over $845M and were named a top workplace with a culture of curiosity and agency.
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.
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 biostatistics function for oncology clinical trials, including study design and statistical analysis.
Partner with clinical and regulatory teams to author key documents and ensure data quality.
Represent biostatistics in interactions with CROs and regulatory agencies to ensure project success.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life. They have multiple global Phase 3 clinical studies and a team of world-class professionals driven by core values of integrity, passion, and collaboration.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
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.
Manage regulatory submission planning, publishing, and lifecycle management for clinical programs.
Serve as SME for eCTD structure, validation, and document management technologies.
Drive process improvements and ensure compliance with Health Authority requirements.
Exelixis is a biotech company dedicated to discovering and developing innovative medicines for difficult-to-treat cancers. With over 25 years of experience, they foster a collaborative and inclusive culture focused on making a difference for patients.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
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.