Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.
Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
Write and manage investigational regulatory submissions for US, EU, and ROW.
Support risk mitigation and GMP compliance across development programs.
Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.
Serve as subject matter expert defining gold standard for regulatory content on an AI platform.
Ensure outputs reflect current agency expectations and are ready for global submission.
Work flexibly 5–20 hours per week in a remote, US-based role.
Edison Scientific builds and commercializes AI agents for science. They are assembling a team of top researchers and engineers across AI and biology with a fast-moving, mission-driven culture.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.
Veristat accelerates life-changing therapies to patients worldwide with more than 30 years of expertise. They have a flexible, inclusive culture with 70% remote workforce and 66% women-led teams, having prepared over 105 approved therapies and delivered over 350 rare disease projects.
Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.
Lead integrated drug development strategies across preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies.
Engage with global regulatory authorities and support portfolio management, licensing, and business development decisions.
Jobgether uses AI-powered matching to connect candidates with hiring companies. They process applications efficiently and share shortlists with employers, supporting a global, inclusive work environment focused on innovation.
Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio.
Oversees global product registrations, device licensing, and market authorization activities.
Provides leadership and expert guidance on emerging regulations and standards.
Merative provides data, analytics, and software for health and social care. It is a medium-to-large company with a remote-first culture and values focus, speed, trust, and inspire.
Develop global clinical strategies to support clinical evidence requirements for product submissions.
Ensure adequate monitoring is conducted on all clinical trials and work directly with regulatory bodies for approvals.
Select, interface with, and assure training of investigators, physicians, and clinical staff.
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Lead and personally execute biologics CMC consulting engagements as the primary technical point of contact across program lifecycle.
Establish and grow Syner-G's presence in the West Coast biologics market, focusing on Bay Area, San Diego, and Seattle biotech corridors.
Provide expert guidance across biologics development including upstream and downstream process development, analytical characterization, and CMC regulatory strategy.
Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and delivery of life-enhancing therapies. The company has been honored with BioSpace's prestigious 'Best Places to Work' award for three consecutive years, fostering a culture focused on career growth, development opportunities, and financial rewards.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Lead programming activities for oncology clinical trials, developing and validating SDTM and ADaM datasets following CDISC standards.
Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and regulatory submissions.
Collaborate with Biostatistics, Data Management, and Regulatory Affairs to ensure compliance with FDA, EMA, and PMDA requirements.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience, they employ more than 4,000 professionals across 20+ countries, fostering a culture of diversity and continuous training.