Global Regulatory Affairs Device Lead (Associate Director)

Role Summary

Global Regulatory Affairs Device Lead (Associate Director) at Sanofi. Location: Morristown, NJ or Cambridge, MA or Framingham, MA. Drive global regulatory strategies for medical device and combination products, collaborate with cross-functional teams, and influence product approvals through negotiations with health authorities worldwide.

Responsibilities

• Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device parts of combination products
• Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identify medical device regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submissions timelines; ensure communication, resolution and escalation as needed
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
• Prepare, review and approve design control deliverables
• Contribute to product development and lifecycle management planning
• Provide regulatory impact assessments for proposed product changes
• May serve as regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit
• Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
• Contributes to the development of a harmonized One Sanofi regulatory voice through device committees/forums
• Supports operational and compliance activities for assigned deliverables, develops regulatory submission planning activities including submission content plans, submission tracking, communication and document management
• Contribute to internal regulatory processes and procedures for medical devices
• Accountable for regulatory assessment for medical devices Due Diligence activities as applicable

Qualifications

• Experience: 8+ years in pharmaceutical/biotechnology/medical device industry; 5+ years in medical device and/or combination product regulatory experience with regulatory filings and strategies; experience responding to Health Authority questions
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of clinical development of medicinal products, device/IVD development (design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of technical/industry standards related to medical devices
• Collaboration Skills: Ability to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing and negotiation skills
• Soft Skills: Strategic thinking, initiative, change agent leadership and risk assessment proficiency
• Education: Bachelor's in scientific or engineering discipline; graduate degree preferred
• Communication: Strong written and verbal communication and influencing skills, fluent in English
• Adaptability: Ability to manage multiple projects in a fast-paced hybrid environment (60% on-site)

Skills

• Regulatory strategy development for medical devices and combination products
• Health Authority liaison and interactions planning
• Regulatory submissions planning, tracking, and management
• Design controls and regulatory impact assessments
• Cross-functional collaboration and stakeholder management

Education

• Bachelor‚Äôs degree in a scientific or engineering discipline. Graduate degree preferred.