GRA Device Lead (Associate Director)

GRA Device Lead (Associate Director)

Sanofi

Frankfurt am Main, Germany

As GRA Device Lead in the GRA Device, General Medicine and Vaccine Medical Device and Combination Product team you’ll drive global regulatory strategies for medical device and combination products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide. Ready to get started?

The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of combination products, from pre-filled syringes, pen injectors, autoinjectors, large volume devices and other innovative technologies. Working at the intersection of science and compliance, you'll develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends - all contributing directly to bringing innovative therapies to patients worldwide.

Main 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 part of combination products elements;
• Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions;
• Identifies medical device regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT;
• Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or 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 a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed;
• 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 participation in appropriate device committees, forums;
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating 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.

May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the additional responsibilities:

• The dGRL is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in order to meet corporate and business objectives;
• Leads the Device GRT, for fosters team performance by aligning team on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy;
• Ensures alignment and communication internally and externally as “one GRA voice” to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate;
• The dGRL is the single GRA point of contact for the medical device program and represents GRA at the Device Team, the Global Project Team, and internal governance committees.

About you

This position requires an experienced regulatory affairs professional with familiarity with international submissions from within a global healthcare organization. You will have had experience in large organizations given the need to be able to interact across the Sanofi organization.

• Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory 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 (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to medical devices. Ability to synthesize and critically analyze data from multiple sources;
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills;
• Soft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies;
• Education: Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.;
• Communication: Strong written and verbal communication and influencing skills, with fluency in English;
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.