Eacademy Sanofi
Overview
Job Title:
GRA Device Lead (Associate Director)
Location : Morristown, NJ / Cambridge, MA / Framingham, MA
The Global Regulatory Affairs (GRA) Device team supports medical device, combination product, digital health and in vitro diagnostic (IVD) products within the Sanofi portfolio. The team develops and implements global regulatory strategies for device and IVD products across the product lifecycle and collaborates with Global Regulatory Affairs, Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, and Regulatory Health Authorities to ensure compliance and optimize product approval pathways. The team leads regulatory efforts in development and post-marketing stages and serves as a strategic partner bridging technical development, manufacturing operations, and regulatory authorities.
As GRA Device Lead in the GRA Device Specialty Care Device and Combination Products team, you’ll 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, from prefilled syringes and injectors to other innovative technologies, and involves preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends.
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/device aspects of medicinal product submissions.
Liaise with device, clinical, manufacturing, commercial, and other internal business 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.
Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations.
Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in device committees and forums.
Supports operational and compliance activities for assigned deliverables, including regulatory submission planning, 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 of relevant 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, strong leadership, influencing and persuasive negotiation skills.
Soft Skills:
Strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall 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 fluency in English.
Adaptability:
Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Grow your talent and career through promotions or lateral moves, at home or internationally.
Enjoy a rewards package that recognizes your contribution and impact.
Health and wellbeing benefits including comprehensive healthcare and at least 14 weeks’ gender-neutral parental leave.
Play a crucial role in bringing innovative therapies to patients worldwide, at the forefront of drug discovery and development with a patient-centric approach.
Leverage AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.
Engage with diverse teams spanning scientific, clinical, and digital fields, fostering cross-functional collaboration.
Structured career paths offering scientific and leadership advancement opportunities, including short-term projects to expand expertise.
Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective.
Supportive R&D environment with flexible working options (60% on-site) and wellbeing programs.
Influence global regulatory strategies and interact with health authorities, staying at the forefront of industry trends.
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 required during the recruitment process are available upon request.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
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.
#J-18808-Ljbffr
GRA Device Lead (Associate Director)
Location : Morristown, NJ / Cambridge, MA / Framingham, MA
The Global Regulatory Affairs (GRA) Device team supports medical device, combination product, digital health and in vitro diagnostic (IVD) products within the Sanofi portfolio. The team develops and implements global regulatory strategies for device and IVD products across the product lifecycle and collaborates with Global Regulatory Affairs, Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, and Regulatory Health Authorities to ensure compliance and optimize product approval pathways. The team leads regulatory efforts in development and post-marketing stages and serves as a strategic partner bridging technical development, manufacturing operations, and regulatory authorities.
As GRA Device Lead in the GRA Device Specialty Care Device and Combination Products team, you’ll 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, from prefilled syringes and injectors to other innovative technologies, and involves preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends.
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/device aspects of medicinal product submissions.
Liaise with device, clinical, manufacturing, commercial, and other internal business 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.
Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations.
Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in device committees and forums.
Supports operational and compliance activities for assigned deliverables, including regulatory submission planning, 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 of relevant 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, strong leadership, influencing and persuasive negotiation skills.
Soft Skills:
Strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall 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 fluency in English.
Adaptability:
Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Grow your talent and career through promotions or lateral moves, at home or internationally.
Enjoy a rewards package that recognizes your contribution and impact.
Health and wellbeing benefits including comprehensive healthcare and at least 14 weeks’ gender-neutral parental leave.
Play a crucial role in bringing innovative therapies to patients worldwide, at the forefront of drug discovery and development with a patient-centric approach.
Leverage AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.
Engage with diverse teams spanning scientific, clinical, and digital fields, fostering cross-functional collaboration.
Structured career paths offering scientific and leadership advancement opportunities, including short-term projects to expand expertise.
Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective.
Supportive R&D environment with flexible working options (60% on-site) and wellbeing programs.
Influence global regulatory strategies and interact with health authorities, staying at the forefront of industry trends.
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 required during the recruitment process are available upon request.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
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.
#J-18808-Ljbffr