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.
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.
Lead medical writing for one or more clinical programs and drive content strategy for clinical and regulatory documents.
Author and manage high-quality clinical study protocols, investigator's brochures, clinical study reports, and global regulatory submissions.
Collaborate cross-functionally, mentor direct reports, and incorporate process improvements to support R&D needs.
Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.
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.
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.
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 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.
Provide strategic medical leadership across oncology clinical programs as a trusted advisor to sponsors and teams.
Serve as Medical Monitor, overseeing patient safety, data interpretation, and safety collaborations.
Represent the organization at client meetings and conferences, mentoring medical directors and improving processes.
Precision Medicine Group is a global precision medicine-focused provider of clinical development and commercial services. The company fosters a collaborative culture centered on scientific excellence, integrity, and patient care, with a diverse international team.
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.
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.
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.
Lead global analytical development and QC strategy across the pipeline.
Oversee GMP operations, regulatory submissions, and FDA/CVM interactions.
Build and scale the AD organization, managing methods, stability, and outsourcing.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.
Participate in Ro’s cross-functional advertising review process, evaluating creative assets for FDA advertising and promotion compliance.
Review product claims and claim substantiation to assess regulatory risk and level of support required.
Stay abreast of changes in FDA regulations and maintain company-wide advertising guidelines.
Ro is a direct-to-patient healthcare company that provides telehealth, labs, and pharmacy services nationwide. Since 2017, the company has helped millions of patients and is consistently recognized as a top workplace in healthcare, earning multiple honors from Fortune, Great Place to Work, and PEOPLE.
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 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 development and execution of medical marketing initiatives for DT120 commercial launch
Drive KOL engagement, advisory boards, and medical congress strategies
Synthesize insights and lead scientific communication materials to support launch readiness
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop treatments for psychiatric and neurological disorders. Headquartered in New York and publicly traded on Nasdaq, the company fosters a culture of relentless innovation and collaboration to move psychiatry forward.
Provide statistical leadership for oncology clinical development programs, including Phase I–III trials and regulatory submissions.
Lead development of SAPs, sample size calculations, randomization strategies, and ensure quality of statistical deliverables.
Collaborate with cross-functional teams, serve as statistical SME, and mentor junior biostatisticians.
ClinChoice is a global full-service CRO delivering clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies. With over 4,000 professionals in 20+ countries, we are committed to high-quality delivery, continuous training, and a diverse, inclusive culture.
Provide strategic and operational leadership across multiple clinical programs, translating development strategy into strong execution.
Oversee clinical trial planning, budgets, CRO/vendor relationships, and cross-functional collaboration to ensure quality and accountability.
Lead and develop a small Clinical Operations team while remaining hands-on in a fast-paced biotech environment.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune diseases. The company fosters an inclusive culture valuing curiosity, creativity, and shared accountability, empowering employees to drive breakthroughs.
Lead ongoing clinical data review to ensure quality, interpretation, and patient safety across development programs.
Develop and review study protocols, investigator brochures, and regulatory documents in partnership with cross-functional teams.
Represent Clinical Development on study teams and present clinical data and scientific information to internal and external audiences.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune disease. They cultivate an inclusive culture valuing curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Establish and maintain peer relationships with key opinion leaders and act as the primary clinical/scientific resource to healthcare providers.
Support evidence generation initiatives, identify gaps in research, and report medical insights to inform strategy.
Attend medical conferences, respond to scientific requests, and ensure compliance with FDA regulations and company policies.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, it has an award-winning culture and has produced multiple FDA-approved treatments.