Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)

Job Title: Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)

Location: Cambridge, MA or 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 Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory activities associated with Sanofi’s combination product and medical device portfolio in the Specialty Care R&D and commercial product ranges. The team is comprised of direct reports and matrix team members. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. The incumbent will work closely with key stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply (device development, manufacturing, quality, supply chain) and Global Business Units. Medical device technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. 

This critical and highly visible position offers the successful candidate the opportunity to lead a team of colleagues working on combination product and medical device technologies, from pre-filled syringes, autoinjectors, pen injectors, nasal sprays, large volume injectors and other innovative combination product technologies, all of which are part of Sanofi’s exciting development pipeline.

The GRA Device team is a globally diverse team supporting the medical device, combination product, biosurgery, 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. 

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:

• Lead, supervise and coach a team of regulatory professionals and be responsible for the development of direct reports

• Contribute to strategy, planning, and execution of the device regulatory deliverables for the product range

• Oversee and review device regulatory strategies of the assigned team and matrix team members leading products in the portfolio

• Participate in peer reviews of device regulatory strategies

• Support development, review and alignment of cross-product device regulatory positions and regulatory dossier templates

• Act as the Regulatory Affairs–Devices lead on assigned project teams (early phase, late stage and marketed products), taking the role as the GRA Device representative in project/product teams

• Develop innovative and sustainable medical device regulatory strategies

• Provide regulatory guidance and advice to development teams

• Prepare regulatory design control deliverables and review and approve design control deliverables

• Lead and/or support global filing activities for medical devices and device aspects of molecule-driven submissions

• Contribute to product development planning, including strategies to bridge drug delivery systems during development

• 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

• Support establishment of internal regulatory processes and procedures for medical devices and devices associated with molecule programs

• Engage with the relevant regulatory bodies and industry groups to influence medical device industry standards and regulations, ensuring that Sanofi’s best interests are represented

About You

This position requires a seasoned regulatory affairs professional with proven international experience from within a global healthcare organization. You will have had experience in large and complex biopharmaceutical organizations given the need to be able to interact across the Sanofi organization. The ability to think outside the box, assure that Regulatory Affairs is seen as a credible and “value adding” partner and getting a talented team recognized as such will also be key deliverables.

Knowledge:

• Proven experience in global medical devices regulatory for drug-led combination products and standalone drug delivery devices

• Working knowledge with technical/industry standards related to combination products and standalone drug delivery medical devices

• Foundational understanding of Artificial Intelligence and impact on industry is highly preferred

• Proven ability to work cross-functionally in a highly professional global environment

Skills and Qualifications:

• At least 10 years of experience in the global healthcare industry with relevant medical device / combination product regulatory experience

• Bachelor’s degree in a scientific or engineering discipline is the minimum educational requirement. Master's degree or other post graduate degree in relevant field is preferred

• Experience in managing people in either a project or functional context

• Poven 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

• Ability to travel internationally

Soft skills:

• 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 staff

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

• 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

• Patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with Sanofi’s behavioral and ethical standards

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.