GRA Device Lead

Job Title: GRA Device Lead

Location: Morristown, NJ, Cambridge, MA, Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The GRA 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 Research and Development. 

Sanofi’s global regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination Products will oversee key regulatory activities and report to the GRA Device Team Leader for Specialty Care Combination Products, who in turn reports to the Head of GRA Device.  The candidate will work within a matrix environment, operating as a strong independent contributor on assigned projects. The role will represent the GRA Device perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain device aspects of project regulatory strategy documents.

The incumbent will provide strategic and tactical support on Sanofi’s combination product portfolio and will also have the opportunity to work on other innovative projects. The incumbent 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. The incumbent will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. The incumbent has a patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with Sanofi’s behavioral and ethical standards.

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. 

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 regulatory design control deliverables.

• Review and approve design control deliverables.

• Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions.

• Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.

• Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.

• Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.

• Lead and/or support device related health authority interactions.

• Provide regulatory impact assessments for proposed product changes.

• 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

Knowledge:

• Sound understanding of and experience with global regulatory requirements for combination products and drug 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 ability to work cross-functionally in a highly professional global environment.

Skills/Qualifications:

• M.S. degree –in a scientific or engineering discipline –with 6 years regulatory experience, or B.S. with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required.

• At least 10 years experience in the global healthcare industry.

• 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.

• Ability to synthesize and critically analyze data from multiple sources.

• Dynamic personality, ability to think outside the box.

• Demonstrates excellent communication and influencing skills internally and externally and in particular the ability to impact and influence decisions on global teams, both written and verbal, in English.

• Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing.

• Demonstrate strong organizational skills, including the ability to prioritize workload and capacity to work under pressure.

• Ability to travel internationally.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• 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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