Lead global regulatory strategy for assigned programs, overseeing processes and managing risks to achieve successful registration and lifecycle management.
Collaborate cross-functionally with teams including toxicology, pharmacology, and clinical development to support clinical programs and regulatory submissions.
Serve as point of contact with health authorities, interpret regulatory guidelines, and drive innovative approaches to regulatory sciences.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Lead operational and lifecycle management of Regulatory CMC submissions for cell therapy programs.
Develop and execute global regulatory CMC strategies aligning with program objectives.
Serve as Regulatory CMC lead on cross-functional teams, providing strategic guidance.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. It operates as a small, mission-driven company in a fast-paced environment.
Serve as the CDx regulatory subject matter expert, developing global regulatory strategies for companion diagnostics and clinical trial assays.
Lead interactions with regulatory authorities and direct the preparation of global submissions, including FDA Q-Submissions, IDEs, PMAs, and EU IVDR applications.
Partner cross-functionally with pharmaceutical and diagnostic clients to align diagnostic development with therapeutic milestones and commercialization objectives.
Precision Medicine Group provides regulatory consulting services to pharmaceutical, biotechnology, and diagnostic clients, specializing in companion diagnostics and precision medicine. The company fosters a collaborative, client-focused culture with a team of regulatory experts.
Provide strategic regulatory leadership for companion diagnostics (CDx) and precision medicine programs across global markets.
Lead consulting engagements, guiding clients through FDA, EU IVDR, and international regulatory pathways from development to commercialization.
Mentor consulting team members and contribute to a collaborative regulatory practice focused on precision medicine innovation.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It operates remotely with a focus on efficiency and data privacy.
Provide strategic pharmaceutical development guidance as CMC lead to cross-functional project teams.
Develop robust formulations and manufacturing processes to support rapid registration of QED products.
Manage CRO relationships, drug forecasts, and regulatory submissions for clinical supply.
BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.
Lead regulatory and quality strategy for product development and lifecycle management.
Coordinate regulatory submissions and maintain documentation for SaMD products.
Support design change assessments and ensure compliance with FDA, EU MDR, and ISO 13485.
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.
Develop and execute US Medical Affairs strategy for evidence generation across tumor types, collaborating with internal and external stakeholders.
Provide strategic input into Global Integrated Strategic Plan and Plan of Action for ADC portfolio.
Prepare and present scientific data at internal meetings and external advisory boards.
Gilead is a biopharmaceutical company dedicated to advancing innovative medicines for life-threatening diseases like HIV, viral hepatitis, and cancer. With a global presence in over 35 countries, Gilead fosters a collaborative and inclusive culture focused on scientific excellence.