Sanofi
Overview
Job Title: GRA Device Lead (Associate Director) Location: Morristown, NJ / Cambridge, MA / Framingham, MA 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 team is a globally diverse group supporting medical device, combination product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio. The team is part of the GRA CMC & GRA Device Department within Global R&D and serves as a strategic partner providing expert guidance on medical device regulatory requirements across the product lifecycle. The team develops and implements global regulatory strategies for device and IVD products, leading regulatory efforts in development and post-marketing stages, and collaborates with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others. As GRA Device Lead, you will drive global regulatory strategies for medical device and combination products, collaborate with cross-functional teams to navigate regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through strategic negotiations with health authorities worldwide. The role supports a wide range of combination products, including devices such as prefilled syringes, pen injectors, autoinjectors, and large-volume devices, among others. You will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities while preparing regulatory submissions and ensuring ongoing compliance. Main Responsibilities
Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products).
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams.
Develop and execute innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).
Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions.
Identify medical device regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT.
Identify and manage issues and opportunities that impact submissions timelines; ensure communication, resolution and escalation as needed.
Lead global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions.
Liaise with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes.
Prepare, review and approve design control deliverables.
Contribute to product development and lifecycle management planning. Provide regulatory impact assessments for proposed product changes.
May serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed.
Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations.
Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees and forums.
Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including submission content plans, submission tracking, communication and document management.
Contribute to internal regulatory processes and procedures for MD/IVD.
Accountable for regulatory assessment for MD/IVD Due Diligence activities as applicable.
About You
This position requires an experienced regulatory affairs professional with familiarity with international submissions within a global healthcare organization. Experience in large organizations is preferred to interact across the Sanofi organization. Experience:
8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years in medical device and/or combination product regulatory experience, with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
Regulatory Expertise:
Experience preparing regulatory documentation and familiarity with standard submission processes.
Technical Knowledge:
Understanding of clinical development of medicinal products, device development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to injection devices. Ability to synthesize and critically analyze data from multiple sources.
Collaboration Skills:
Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, leadership, influencing and negotiation skills.
Soft Skills:
Strategic thinking, initiative, change-agent leadership and risk assessment proficiency, with ability to translate business objectives into actionable project strategies.
Education:
Bachelor’s degree in a scientific or engineering discipline. Graduate degree preferred.
Communication:
Strong written and verbal communication and influencing skills, with English fluency.
Adaptability:
Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site).
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Opportunities to grow your talent and career, including promotions or lateral moves, at home or internationally.
Rewards packages that recognize your contribution and impact.
Comprehensive health and wellbeing benefits, including parental leave.
Play a crucial role in bringing innovative therapies to patients worldwide.
Leverage AI, data, and digital platforms to advance regulatory strategy.
Engage with diverse teams across scientific, clinical, and digital fields.
Structured career paths with scientific and leadership advancement opportunities.
Commitment to diversity, equity, and inclusion.
Flexible on-site work options and well-being programs.
Influence global regulatory strategies and interact with health authorities.
Sanofi is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities are available during the recruitment process upon request. US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a diverse workforce. All qualified applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, nationality, sex, gender, gender identity or expression, disability, veteran or military status, or any other characteristic protected by law. North America Applicants Only The salary range for this position is $147,000.00 - $212,333.33. All compensation determined commensurate with experience. Employees may be eligible to participate in company benefit programs. Additional benefits information can be found through the company intranet.
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Job Title: GRA Device Lead (Associate Director) Location: Morristown, NJ / Cambridge, MA / Framingham, MA 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 team is a globally diverse group supporting medical device, combination product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio. The team is part of the GRA CMC & GRA Device Department within Global R&D and serves as a strategic partner providing expert guidance on medical device regulatory requirements across the product lifecycle. The team develops and implements global regulatory strategies for device and IVD products, leading regulatory efforts in development and post-marketing stages, and collaborates with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others. As GRA Device Lead, you will drive global regulatory strategies for medical device and combination products, collaborate with cross-functional teams to navigate regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through strategic negotiations with health authorities worldwide. The role supports a wide range of combination products, including devices such as prefilled syringes, pen injectors, autoinjectors, and large-volume devices, among others. You will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities while preparing regulatory submissions and ensuring ongoing compliance. Main Responsibilities
Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products).
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams.
Develop and execute innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).
Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions.
Identify medical device regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT.
Identify and manage issues and opportunities that impact submissions timelines; ensure communication, resolution and escalation as needed.
Lead global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions.
Liaise with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes.
Prepare, review and approve design control deliverables.
Contribute to product development and lifecycle management planning. Provide regulatory impact assessments for proposed product changes.
May serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed.
Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations.
Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees and forums.
Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including submission content plans, submission tracking, communication and document management.
Contribute to internal regulatory processes and procedures for MD/IVD.
Accountable for regulatory assessment for MD/IVD Due Diligence activities as applicable.
About You
This position requires an experienced regulatory affairs professional with familiarity with international submissions within a global healthcare organization. Experience in large organizations is preferred to interact across the Sanofi organization. Experience:
8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years in medical device and/or combination product regulatory experience, with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
Regulatory Expertise:
Experience preparing regulatory documentation and familiarity with standard submission processes.
Technical Knowledge:
Understanding of clinical development of medicinal products, device development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to injection devices. Ability to synthesize and critically analyze data from multiple sources.
Collaboration Skills:
Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, leadership, influencing and negotiation skills.
Soft Skills:
Strategic thinking, initiative, change-agent leadership and risk assessment proficiency, with ability to translate business objectives into actionable project strategies.
Education:
Bachelor’s degree in a scientific or engineering discipline. Graduate degree preferred.
Communication:
Strong written and verbal communication and influencing skills, with English fluency.
Adaptability:
Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site).
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Opportunities to grow your talent and career, including promotions or lateral moves, at home or internationally.
Rewards packages that recognize your contribution and impact.
Comprehensive health and wellbeing benefits, including parental leave.
Play a crucial role in bringing innovative therapies to patients worldwide.
Leverage AI, data, and digital platforms to advance regulatory strategy.
Engage with diverse teams across scientific, clinical, and digital fields.
Structured career paths with scientific and leadership advancement opportunities.
Commitment to diversity, equity, and inclusion.
Flexible on-site work options and well-being programs.
Influence global regulatory strategies and interact with health authorities.
Sanofi is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities are available during the recruitment process upon request. US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a diverse workforce. All qualified applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, nationality, sex, gender, gender identity or expression, disability, veteran or military status, or any other characteristic protected by law. North America Applicants Only The salary range for this position is $147,000.00 - $212,333.33. All compensation determined commensurate with experience. Employees may be eligible to participate in company benefit programs. Additional benefits information can be found through the company intranet.
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