Sr. Manager, 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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HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
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 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 the 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 and 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. In-vitro diagnostics and drug delivery device systems technology are 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 and combination products, including pre-filled syringes, autoinjectors, pen injectors, diagnostic reagents, and companion and complementary diagnostics, all of which are part of Sanofi’s exciting development pipeline.
- Serve as GRA-Devices lead or support the GRA-Devices lead on assigned project teams (early phase, late-stage and marketed products), supporting combination product and/or diagnostics device aspects.
- Develop innovative and sustainable medical device regulatory strategies covering diagnostic and combination products (device elements).
- Prepare regulatory design control deliverables.
- Review and/or approve design control deliverables.
- Lead and/or support global filing activities for diagnostics and device aspects of combination product submissions.
- Lead and/or 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 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.
- Understanding of and experience with global regulatory requirements for in-vitro diagnostics, delivery systems and technical/industry standards related to clinical laboratory requirements and drug delivery systems.
- 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.
- M.S. degree –in a scientific or engineering discipline –with 5 years regulatory experience, or B.S. with 8 years regulatory experience. At least 3 years of relevant diagnostics and/or combination product regulatory experience required.
- At least 8 years’ in the global healthcare industry.
- Proven experience with in-vitro diagnostics and drug/device combination product regulatory strategies and approvals.
- Ability to synthesize and critically analyze data from multiple sources.
- A 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.
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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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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