Review and approve post-marketing Individual Case Safety Reports and Serious Adverse Event reports for medical assessment, including coding and causality.
Support signal detection activities, review aggregate reports like PBRERs and DSURs, and provide input for Risk Management Plans and regulatory responses.
Utilize advanced English and Japanese language skills to collaborate cross-culturally with global teams and clients, ensuring high-quality pharmacovigilance services.
PrimeVigilance is a specialized pharmacovigilance service provider offering support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology partners globally. It is a mid-size company that values employee training, well-being, and a healthy work-life balance, fostering a collaborative, human-centric environment with team members across continents.
Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2).
Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies.
Proactively identify and communicate potential risks and define mitigation strategies.
Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Their work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Support regulatory operations for SaMD products across development, submission, launch, and post-market phases
Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
Maintain regulatory documentation, including: submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
Drive product registrations in Asia, focusing on East and Southeast Asian countries.
Conduct regulatory assessments of formulas and labels for compliance with country-specific requirements.
Develop market-specific substantiation guidelines for claims and review marketing materials.
Niagen Bioscience uncovers the potential of NAD+ with precision science and creates solutions to help people Age Better. Our collaborative environment embodies "C.H.E.", emphasizing Character, Horsepower, and Experience.