Job title : GRA Device Lead (Associate Director)

Location: Cambridge. MA , Morristown, NJ

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.

The selected candidate will oversee key regulatory activities and report to the Global Regulatory Device Head for Digital Health and Diagnostics, who in turn reports to the Head of GRA Medical Devices. The candidate will work in a matrix role, operating as an independent contributor on assigned projects and/or providing support on assigned projects with the diagnostics and/or combination product platform regulatory lead(s). 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 diagnostics 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. In-vitro diagnostics is often exploring new territories that need “new” thinking and approaches from a regulatory perspective.

This highly valuable position offers the successful candidate the opportunity to support a wide range of diagnostics, including diagnostics used in medicinal product clinical trials, diagnostic reagents and companion and complimentary diagnostics, 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 GRA-Devices lead on assigned project teams (early phase, late stage and marketed products), supporting diagnostics device aspects;

• Develop innovative and sustainable medical device regulatory strategies covering diagnostic (device elements);

• Prepare regulatory design control deliverables;

• Review design control deliverables;

• Lead and/or support global filing activities for diagnostics and diagnostics aspects of medicinal product submissions;

• Support device related health authority interactions;

• Provide regulatory impact assessments for proposed product 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

• 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 diagnostics and medical devices.

• 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

• Understanding of and experience with global regulatory requirements for in-vitro diagnostics and technical/industry standards related to clinical laboratory requirements;

• Basic understanding of regulations and guidelines related to drug development and registration is required;

• 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 8 years regulatory experience. At least 3 years of relevant diagnostics regulatory experience required;

• At least 10 years in the global healthcare industry;

• Proven experience with in-vitro diagnostics regulatory strategies and approvals;

• 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 staff;

• Demonstrate strong organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities including the ability to prioritize workload and capacity to work under pressure;

• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

• Independently motivated, detail oriented and good problem-solving ability

• Ability to travel internationally

Inspire your Journey, what Sanofi can offer you:

• 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

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.

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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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)