Our Team: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.Position Overview:Sanofi’s global regulatory affairs (GRA) function is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine Combination Products will oversee key regulatory activities and report to the GRA Device Team Leader for Specialty Care & Vaccine 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.Key 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 activities for device aspects of combination product submissions.
Contribute to product development planning, including strategies to bridge 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.
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.
Knowledge:
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 ability to work cross-functionally in a highly professional global environment.
Skills/Qualifications:
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 relevant experience.
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 (minimal).
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
This is our Sanofi, Discover yours.At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.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.#GD-SA#LI-SAPursue progress , discover extraordinaryBetter 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) !