Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.
Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.
Provide technical and regulatory support to Compliance Managers and Senior Advisors, ensuring product documentation meets client policies.
Prepare, verify, check, and approve product documentation using supplier information, reporting any non-compliance.
Apply client's new and updated policies, regulatory, and technical requirements; maintain awareness of microbiology and nutritional analysis.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 100,000 employees operating across 2,600 offices and laboratories, SGS fosters a culture of trust, reliability, and innovation to enable a better, safer, and more interconnected world.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.
The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.
Secure regulatory approvals for innovative medical devices in the Indian market.
Collaborate with global regulatory teams on submissions, documentation, and compliance.
Interpret local regulations and support BIS certification and import/export requirements.
The company develops innovative medical devices and operates in a global healthcare technology environment. It values regulatory compliance, cross-functional collaboration, and professional growth, with a remote-friendly and internationally connected culture.
Serve as a technical lead and device subject matter resource across the medical device total product life cycle.
Analyze premarket and postmarket submissions, evaluating safety, effectiveness, and benefit-risk determinations.
Develop SOPs, real-world evidence protocols, and risk standards grounded in FDA guidance while mentoring junior engineers.
ICA, Inc. is a rapidly growing government consulting firm providing innovative solutions in public health research, advanced data science, and strategic services. Our small but collaborative team prioritizes work-life balance and supports dynamic, highly skilled professionals.
Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Provide scientific, strategic, and commercial leadership for Product Safety Labs' medical device biocompatibility business.
Collaborate with Study Directors, laboratory management, and business development to strengthen scientific capabilities and expand service offerings.
Represent PSL through client engagement, scientific presentations, publications, and standards committees.
Eurofins Scientific is an international life sciences company providing analytical testing services to make life and our environment safer, healthier and more sustainable. With over 58,000 staff across 900 laboratories in more than 54 countries, Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing.
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.