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.
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.
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.
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.
Build and lead the US Field Medical Affairs organization, including hiring and managing a high-performing MSL team.
Implement field strategy in alignment with clinical development and launch plans, and oversee MSL training and analytics.
Collaborate internally and externally, track KPIs, and ensure compliance with regulations while engaging key opinion leaders.
The job posting states: 'Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.'
Lead and manage the clinical operations team, setting and executing departmental strategy.
Oversee clinical trial agreements, budgets, expenditures, and ensure timely execution of clinical programs.
Establish and maintain good working relationships with clinical study site personnel and oversee study conduct.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer. The company is pioneering a transformational approach to treating cancer and is committed to continuous innovation in cell therapy, including gene-edited cell therapy.
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.
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.
Lead and manage all drug safety functions for investigational products across the organization.
Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
Collaborate cross-functionally to ensure compliance and advance patient safety.
BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.