GRA Device Associate, Combination Products Senior Manager
Overview
You will own global regulatory strategies for medical devices and combination products across Sanofi's portfolio, including pre-filled syringes, autoinjectors, and other innovative technologies. Partner with the Device Regulatory Lead to navigate complex regulatory landscapes and influence product approvals through strategic negotiations with health authorities. Collaborate with cross-functional teams in R&D, Device, Manufacturing, and Quality, while preparing high-quality submissions and managing compliance. This role offers direct exposure to diverse combination products and the chance to shape regulatory pathways from development to post-marketing stages.
What You'll Do9
- 1Partner with the Device Regulatory Lead to execute device regulatory strategies for assigned projects.
- 2Provide regulatory guidance to Global Regulatory Team and cross-functional stakeholders.
- 3Identify regulatory acceleration opportunities and risks, and propose risk mitigations in collaboration with the team.
- 4Support global filing and lifecycle management for device submissions and device aspects of medicinal product filings.
- 5Liaise with device, clinical, manufacturing, and commercial partners to enable successful regulatory outcomes.
- 6Prepare and review design control deliverables.
- 7Contribute to product development and lifecycle management planning, including regulatory impact assessments for proposed changes.
- 8Support Health Authority interactions, including preparing materials and responding to questions.
- 9Develop and execute submission plans, tracking, communication, and document management for assigned deliverables.
Requirements10
- 1Bachelor's degree in a scientific or engineering discipline; advanced degree (Master or PhD) preferred.
- 26+ years in pharmaceutical, biotechnology, or medical device industry.
- 33+ years of regulatory experience in CMC, device, or combination product, with contributions to filings and strategy implementation.
- 4Experience responding to Health Authority questions.
- 5Familiarity with implementing device regulatory strategies for product development, clinical use, and commercialization, including change controls.
- 6Understanding of drug clinical development, device development (including design controls), and technical/industry standards for medical devices.
- 7Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams.
- 8Strong leadership, influencing, and negotiation skills with business acumen.
- 9Strategic thinking, initiative, and risk assessment proficiency, integrating business objectives into actionable strategies.
- 10Fluency in English with strong written and verbal communication skills.
Salary Insight
$122 - $177k per year
Location
Required Skills
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