GRA Device Lead (Associate Director) - all genders

Sanofi US; Frankfurt; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global biopharma company is seeking a GRA Device Lead to manage regulatory strategies for medical devices and combination products. The ideal candidate will have over 8 years of experience in the pharmaceutical industry, strong regulatory expertise, and collaborative skills. This role involves preparing global regulatory submissions and working closely with various teams to ensure successful outcomes, in a hybrid work environment based in Frankfurt, Germany.

Leistungen

Structured career paths

Well-being programs

Flexible work options

Qualifikationen

• 8+ years of experience in pharmaceutical/biotechnology/medical device industry.
• 5+ years in medical device regulatory work.
• Strong written and verbal skills in English.

Aufgaben

• Serve as GRA Device Lead on assigned project teams.
• Develop and execute innovative medical device regulatory strategies.
• Lead global filing and lifecycle management for device submissions.

Kenntnisse

Regulatory documentation preparation

Collaboration in a matrix environment

Strategic thinking

Risk assessment

Ausbildung

Bachelor’s degree in scientific or engineering discipline

Graduate degree preferred

Jobbeschreibung

About the job

The Global Regulatory Affairs (GRA) Device team supports the medical device, combination product, digital health, and IVD products within the Sanofi portfolio. The GRA Device organization serves as a strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. The team develops and implements global regulatory strategies for device and IVD products and leads regulatory efforts in development and post-marketing stages, collaborating with Global Regulatory Affairs, Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, and Regulatory Health Authorities.

As GRA Device Lead in the GRA Device Specialty Care Device and Combination Products team, you’ll drive global regulatory strategies for medical devices and combination products, collaborate with cross-functional teams, optimize product development and manufacturing processes, and influence product approvals through strategic negotiations with health authorities worldwide.

The GRA Device Lead role is a critical and highly visible position offering the opportunity to support a wide range of combination products, from prefilled syringes and pen injectors to autoinjectors and large-volume devices. 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.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering growth. Our pipeline enables us to invent medicines and vaccines that treat and protect millions of people. We pursue science to improve lives.

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 combination products and device elements
• Define device Health Authority interactions plan, lead device-related health authority interactions, and support cross-functional health authority interactions
• Identify regulatory acceleration opportunities and risks; propose risk mitigations with the GRT
• Identify and manage issues and opportunities impacting submissions timelines; ensure communication, resolution, and/or escalation as needed
• Lead global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal 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 remit
• Participate in development and monitoring of global regulatory environment and updates to device standards and processes
• Contribute to a harmonized One Sanofi regulatory voice through device committees and forums
• Support operational and compliance activities for assigned deliverables, including regulatory submission planning, content generation, tracking, and document management
• Contribute to internal regulatory processes and procedures for MD/IVD
• Accountable for regulatory assessment for MD/IVD Due Diligence activities as applicable

About you

This position requires an experienced regulatory affairs professional with familiarity with international submissions from within a global healthcare organization. Experience in large organizations is preferred to interact across the Sanofi organization.

• Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years in medical device and/or combination product regulatory work and experience contributing to regulatory filings and responses 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 development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge of injection device standards. Ability to analyze data from multiple sources
• 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 leadership, and risk assessment skills; ability to align business objectives with 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: Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth

Why choose us?

• Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach
• Leverage AI, data, and digital platforms to advance regulatory strategy
• Collaborate with diverse teams across scientific and digital fields
• Structured career paths offering scientific and leadership advancement
• Commitment to diversity, equity, and inclusion, with programs that value every voice
• Supportive R&D environment with flexible options (60% on-site) and well-being programs
• Influence global regulatory strategies and stay at the forefront of industry trends

Join Sanofi and pursue progress and discovery. We invest in you to grow, think faster, and push boundaries to improve lives.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status, or other legally protected characteristics. Watch our ALL IN video and review our Diversity, Equity, and Inclusion actions at sanofi.com.

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