Source Job

• 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.

• 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.

• 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.

• Lead integrated asset strategy across the full product lifecycle, from research through commercialization.
• Drive strategic planning for emerging therapeutic platform technologies and evaluate portfolio opportunities.
• Partner cross-functionally with Research, Clinical, Regulatory, and Commercial teams to ensure alignment and execution.

Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values, the company is committed to transforming treatment for autoimmune disease.

• Direct strategic change projects across Global Clinical Trial Operations (GCTO) to ensure on-time, high-quality delivery.
• Drive cross-initiative change management efforts, including liaising with change agent networks and aligning training plans.
• Establish process standards and promote best practices for how teams approach projects and initiatives.

Merck & Co., Inc. is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

• Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
• Develops study documents, manages site feasibility, and drives recruitment strategies.
• Leads internal clinical team meetings and ensures quality deliverables through metric reporting.

Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.

• Serve as primary point-of-contact and escalation point for clients, coordinating all functional services and external vendors.
• Manage study budgets, project profitability, and billing compliance to ensure financial health and alignment with scope.
• Develop robust project plans, track metrics, and prepare status updates for clients and senior management.

Precision Medicine Group is a global contract research organization specializing in oncology and precision medicine. The company values collaboration and quality, employing a diverse team of professionals dedicated to advancing clinical research.

• Provide program management expertise and leadership for novel engineered T cell therapies, managing cross-functional development programs.
• Drive execution against critical path activities, track milestones, and communicate risks to senior leadership.
• Influence cross-functional stakeholders to align on priorities, resolve conflicts, and support governance forums.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It is a rapidly growing company driven by core values of innovation and collaboration.

• Provide strategic and technical leadership for CMC activities, overseeing technology transfer, scale-up, and cGMP manufacturing for small molecule drug development.
• Manage contract manufacturing organizations and author regulatory submission sections to ensure alignment and timely achievement of program milestones.
• Collaborate cross-functionally with Quality, Regulatory Affairs, and Supply Chain to support clinical and commercial goals from Phase I through commercialization.

Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare disease. The company is a dedicated team focused on meeting the unique needs of rare patients, fostering a collaborative, diverse, and fast-paced environment centered on patients, courage, community, and collaboration.