Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.
Establish and maintain a system to collect all suspected adverse reaction reports for company products.
Ensure requests from competent authorities for benefit-risk information are answered fully and promptly.
Oversee safety profiles, emerging safety concerns, and post-authorisation safety study commitments.
PrimeVigilance is a mid-size pharmacovigilance service provider and part of Ergomed PLC, supporting pharma and biotech partners with drug safety, regulatory affairs, and quality assurance. With staff across Europe, North America and Asia, it values well-being.
Lead the in-house pharmacovigilance function across clinical development and commercial products, owning the safety database, quality system, and compliance.
Serve as the senior safety physician, making benefit-risk determinations, adjudicating signals, and holding final safety decision authority.
Build and lead the PV team, set standards for AI-enabled safety processes, and ensure inspection readiness and health authority interactions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results, aiming to achieve the impossible together.
Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
Oversee monitoring, compliance, and data analysis while mentoring junior staff.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.
Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
Guide global labeling strategy, document development, and cross-functional regulatory teams.
Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.
A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.