Device Regulatory Lead (Associate Director)

Job title: Device Regulatory Lead (Associate Director)

• Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA

About the job

The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. This critical and highly visible position offers the successful candidate the opportunity to support a wide range of combination products, from pre-filled syringes, autoinjectors, pumps and other innovative combination product technologies, all of which are part of Sanofi’s exciting development pipeline.

You will provide strategic and tactical support on Sanofi’s combination product portfolio and will also have the opportunity to work on other innovative projects. You will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs (Device Development, manufacturing, quality, supply chain) and drug product development. Combination product and drug delivery device systems technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. You will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. Must have a patient and quality focused mindset and drive a culture of continuous improvement in compliance with Sanofi’s behavioral and ethical standards.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities

• Serve as Device Regulatory Lead on assigned project teams (early phase, late stage and marketed products).
• Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).
• Provide regulatory guidance and advice to development teams.
• Prepare, review, and approve regulatory design control deliverables.
• Lead and/or support global filing activities for device aspects of combination product submissions.
• Contribute to product development planning, including strategies to bridge delivery systems during development.
• Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.
• Lead and/or support device related health authority interactions.
• Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
• Contribute to internal regulatory processes and procedures for medical devices and combination products.
• Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi’s best interests are represented.

About you

• At least 10 years of experience in the global healthcare industry. Bachelor’s degree in a scientific or engineering discipline with at least 6 years of relevant combination product regulatory experience or a combination of a Master’s degree and relevant experience.
• Sound understanding of and experience with global regulatory requirements for combination products and delivery systems.
• Working knowledge with technical/industry standards related to drug delivery systems, such as autoinjectors, pumps, etc.
• Solid understanding of regulations and guidelines related to drug development and registration.
• Proven experience in drug/device combination product regulatory approvals.
• Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.
• Dynamic personality, ability to think outside the box.
• Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing.
• Ability to travel internationally (minimal).

Why choose us?

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An individual and well-structured introduction and training when you onboard.
• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
• As a globally successful and constantly growing company, Sanofi provides international career paths as well.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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