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.
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.
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 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.
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.
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.
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 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.
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.
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.
Oversee regulatory labeling activities throughout the product lifecycle, from initial assessments to post-approval updates.
Evaluate regulatory changes, coordinate product information revisions, and prepare Health Authority submissions.
Collaborate with cross-functional teams to maintain compliance with evolving regulatory requirements.
A global clinical research organization dedicated to improving patient outcomes through regulatory affairs and medicinal product compliance. It fosters a collaborative, patient-focused culture with opportunities for professional development.
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.
Manage regulatory submissions and site activation readiness across the UK.
Negotiate budgets and contracts with sites and vendors.
Coordinate with ethics committees and competent authorities for approvals.
Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.
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.
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.
Serve as the Legal representative on the Promotional Review Committee and Medical Review Committee, reviewing HCP-facing, patient-facing, medical, and corporate materials for compliance with FDA regulations and industry codes.
Provide practical legal guidance across pre-launch and launch activities, including patient education, digital content, and patient support programs, balancing legal risk with business objectives.
Review non-promotional materials, evaluate claims for substantiation, and advise on compliantly navigating the regulatory landscape for digital, social, and medical affairs content.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea, and other diseases driven by dysregulated aldosterone. Headquartered in Radnor, Pennsylvania, Mineralys is a fully remote company with a collaborative, fast-moving culture.
Provide administrative and regulatory support for the activation, maintenance, monitoring, and closeout of clinical research studies.
Assist Regulatory Coordinators with regulatory startup, continuing review, amendments, and study closeout activities.
Maintain study regulatory files and binders, ensuring documentation is complete, current, and audit-ready.
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington and operates eight clinical care sites with network affiliations in five states.
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.
Lead safety evaluation and benefit-risk assessments for assigned products.
Support pharmacovigilance and risk management activities across clinical development and marketed products.
Contribute to regulatory submissions and health authority interactions.
Alphanumeric is a staffing and recruiting company that connects specialized professionals with global organizations. It is currently supporting one of the world's largest pharmaceutical companies in filling a contract medical director position.