Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
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.
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.
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.
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.
Manage regulatory activities for complex submissions across EU, GCC, and Australian markets.
Conduct regulatory research, gap analyses, and prepare submission components.
Provide regulatory expertise within multidisciplinary project teams and support business development.
The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.
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.
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.