The Sr. Device Development Engineer leads multidisciplinary teams in developing device combination products, focusing on product management, regulatory compliance, and cross-functional collaboration.

Provide regulatory advertising and promotion expertise across product lifecycle: review and advise on promotional materials, ensure compliance with FDA OPDP/2253 submissions, collaborate with Marketing/Medical/Legal, support global review and labeling input, monitor enforcement and evolving regulations, and manage co-promotion/regulatory relationships.

The Associate Director of Global Development Quality Assurance manages GCP audit programs, oversees staff development, identifies compliance issues, and participates in regulatory inspections with a focus on continuous improvement and best practices.

The Senior Associate Scientist will design in-vitro immunoassays, perform data analysis, maintain cell cultures, and record experimental procedures to aid therapeutic antibody development.

The Senior Clinical Study Lead is responsible for executing large clinical trials, managing study timelines and budgets, leading cross-functional teams, ensuring compliance, and overseeing vendor management and data quality.

The Manager, Clinical Scientist assists in clinical study development, execution, and ensures scientific integrity while collaborating with cross-functional teams.

Responsible for establishing and supporting M365 services including Microsoft Purview and security solutions, optimizing compliance solutions, and collaborating with multi-functional teams.

The role involves drafting and negotiating agreements, advising on data privacy, and collaborating with business units to ensure compliance.

The Senior Manager, Market Access is responsible for developing market access strategies for rare diseases, managing pricing negotiations, monitoring healthcare policies, and ensuring effective communication between global and local teams.

Lead Clinical Database Development to deliver inspection‑ready Medidata Rave EDC solutions. Oversee CRO builds, configure studies and Rave modules, program edit checks/derivations, manage UAT and go‑live, handle amendments and migrations, ensure regulatory compliance (21 CFR Part 11, ICH‑GCP, CDISC), and coach developers while shaping global standards and processes.

The Senior Manager, HEOR will develop evidence packages for HTA submissions, supporting product access and reimbursement through evidence synthesis and strategic alignment with market requirements.

The Commercial Operations Manager will plan and manage sales and marketing support systems, optimize operations, and collaborate with teams to ensure smooth execution of commercial strategies.

The Manager leads brand marketing strategy for oncology in Japan, collaborates with stakeholders, and oversees promotional activities and budgets.

Lead design, planning, and execution of strategic sales initiatives in Japan; oversee analytics and segmentation; manage cross-functional and alliance projects; facilitate leadership meetings; act as senior escalation point; develop team members; identify operational risks and represent Regeneron externally to drive market success.

Lead design, implementation, validation, and support of automated manufacturing processes (DeltaV, Rockwell PLCs, HMI). Own full automation lifecycle (URS, FAT/SAT, IQ/OQ/PQ, CSV), enforce GAMP5/21 CFR Part 11, troubleshoot operations, support commissioning/tech transfer, and drive continuous improvement and reliability.

Execute risk-based audits of operations, controls, third-party arrangements, and SOX 404 processes. Develop audit programs, perform testing per IIA practices, identify control weaknesses, present findings, and assist in drafting reports and recommendations to management and Audit Committee.

Lead pharmacometrics support for R&D programs, delivering PK/PD analyses, high-quality reports, regulatory strategy contributions, and cross-functional scientific communication. Manage small portfolios, solve complex problems, publish scientific work, and interact with regulatory agencies independently.

Lead and develop a team of Clinical Laboratory Study Managers to oversee sample collection, testing, vendor management, study start-up/closeout, data transfer, compliance with ICFs, budgeting/RFPs, training, and cross-functional collaboration to deliver high-quality biospecimens and laboratory data for clinical trials.

This role involves leading regulatory processes for biological products in Japan, including submissions, compliance, and stakeholder interactions.

Lead development and execution of U.S. consumer pulmonology marketing strategy across channels. Oversee media planning/buying, CRM, agency management, cross-functional alignment, regulatory compliance, budgeting, and performance measurement for respiratory indications.