Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
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.
Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
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.
Execute regulatory strategies for obtaining registration approval of Intuitive's medical device portfolio in APAC indirect markets.
Coordinate with Distributor RAs and internal stakeholders to compile regulatory documentation and ensure compliance with medical device regulations.
Manage regulatory submission tracking in systems like Veeva and perform periodic surveillance activities using TrackWise.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to advancing minimally invasive care. The company has built an inclusive and diverse team of great people for over 25 years, grounded in integrity and a strong capacity to learn.
Oversee sterilization processes within medical devices and provide technical support across all certification schemes as a fully remote role.
Lead a team of MDR Product Assessors-Sterilization, manage resource planning, and drive team performance against global targets.
Develop and maintain sterilization QMS documentation aligned with best practices and applicable regulatory requirements.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating a network of 2,600 offices and laboratories, we offer a dynamic, international work environment with a focus on professional development and sustainability.
Drive regulatory strategies for Expanded Access Programs across global markets, ensuring compliance and patient access.
Act as a subject matter expert in communications with pharmaceutical clients, health authorities, and cross-functional teams.
Prepare and submit regulatory dossiers while maintaining up-to-date knowledge of global frameworks.
Jobgether uses AI-powered matching to connect candidates with jobs at partner companies. They are a fast-growing global organization with a dynamic scale-up environment and high autonomy.
Lead authoring and development of high-complexity Phase II-IV clinical regulatory documents for a top pharma partner.
Own the end-to-end medical writing process from planning through final delivery, ensuring alignment with strategy and timelines.
Coordinate cross-functional teams across geographies and facilitate comment resolution to drive document development.
Fortrea delivers solutions that bring life-changing treatments to patients faster. They are a global organization that empowers employees to shape their own career path with comprehensive training and management support.
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 leadership for a comprehensive compliance and ethics program, ensuring adherence to healthcare regulations including HIPAA, Stark Law, and Anti-Kickback Statute.
Develop and implement policies promoting ethical conduct; lead risk assessments, audits, and investigations to strengthen compliance controls.
Advise executive leadership and the Board on compliance trends and regulatory developments; direct compliance education programs.
PT Solutions is a rehabilitation provider expanding access to quality care through physical therapy, occupational therapy, speech-language pathology, and athletic training. They offer industry-leading professional development and are a tight-knit community united in their mission.
Lead pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
Provide medical oversight of safety data and contribute to benefit-risk assessments.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.
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.
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.