Director, Regulatory Affairs Medical Devices
Bridgewater, NJ;Cambridge, MA
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
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Sanofi’s global regulatory affairs (GRA) function is comprised of more than 1800 people. The selected candidate will oversee key regulatory activities and report to the Sr. Director of GRA – Combination Products and Diagnostics, who in turn reports to the Head of GRA Medical Devices. The candidate will work within a matrix environment, operating as a strong independent contributor on assigned projects, aligning strategies with the combination product and diagnostics 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 combination product and 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. 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.
This critical and highly visible position offers the successful candidate the opportunity to support a wide range of diagnostics and combination products, from pre-filled syringes, autoinjectors, pen injectors and innovative combination product technologies, diagnostic reagents and companion and complimentary diagnostics, all of which are part of Sanofi’s exciting development pipeline.
- Serve as Regulatory Affairs – Devices 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 diagnostic assays and 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;
- Establish 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.
- Sound understanding of and experience with global regulatory requirements for diagnostics and delivery systems and technical/industry standards related to clinical laboratory requirements and drug delivery systems, such as auto-injectors, pumps, etc.;
- Solid 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.
- 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 diagnostics 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 staff;
- Demonstrate strong organizational skills, including the ability to prioritize workload and capacity to work under pressure;
- Ability to travel internationally
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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