Sanofi Group Associate/Sr. Associate, Global Regulatory Affairs - Devices in Cambridge (U.S.), Massachusetts

Associate/Sr. Associate, Global Regulatory Affairs - Devices


Sanofi Genzyme focuses on developing specialty treatments fordebilitating diseases that are often difficult to diagnose and treat, providinghope to patients and their families.

Sanofi Genzyme has pioneered the development and delivery oftransformative therapies for patients affected by rare and debilitatingdiseases for over 30 years. We accomplish our goals through world-classresearch, collaboration with the global patient community, and with thecompassion and commitment of our employees. With a focus on specialtyareas including: immunology, oncology and multiple sclerosis, we are dedicatedto making a positive impact on the lives of the patients and families we serve. Sanofi Genzyme's portfolio of transformative therapies, representgroundbreaking and life-saving advances in medicine. As a Sanofi company,Sanofi Genzyme benefits from the reach and resources of one of the world'slargest pharmaceutical companies, with a shared commitment to improving thelives of patients.

At Sanofi Genzyme, we are committed to the growth of our people,connected in purpose by career, life and health.


Thispositionwillprimarilyprovide medical deviceregulatorysupportforSanofi Biosurgery products.Supportpost-marketingchangesatthemanufacturingsite(s)byprovidingprojectteam representationwhileworkingcloselywith Manufacturing,QualityandTechnicalSupportgroups,siteSr.Management, and otherRegulatory Affairs regional and affiliate colleagues.Reviewtechnicaldocumentation(ProjectPlans,ChangeControl,Deviations, CAPA,BatchRecords);Providesupporttochangesformanufacturingandcompliance,ensuring conformancewithexistingregulatoryapprovals.


This position will also provideregulatorysupportforotherprojectsasneeded. In this capacity, the position will providelead and support roles for medical device and drug-device combinations globally.

Major Ac t iv i ties/Key Responsibiliti e s

  • Inspection

  • Coordinatepre-inspectionactivities,includingsubmissionofrequested


  • Participateincorporateauditinspectionpreparationactivities

  • Providemember(s)totheSiteInspectionReadinessTeam

  • Provideinspectionsupportatsites

  • ChangeControls

  • Changecontrolassessments

  • InitialscreeningassessmentofCCRs

  • InitiateRAChangeassessment form in databaseif needed

  • Follow-uponassessmentswith Tier1Countries&ROW

  • ManufacturingSiteSupport

  • DeviationassessmentandInvestigationssupport

  • Documentchanges(SOPs,Protocol,BatchRecords)–i.e.DCR

  • Reviewandsignoffofotherdocs(PVprotocols/ reports,technicalreportsfrom


  • SitePeriodicProductReviews (PPRs) (provideinfotoreportandreview)

  • RepresentRA-Devices atSiteQMR &QualityCouncilMeetings

  • RepresentRA- Devices atChangeControlBoardMeetings

  • ReviewBatchRecordsforupdatesandchanges

  • Point ofContactforSiteSpecificActivitiesandSupport(notHArelated)

  • ProvidesupportforinternalandexternalGMP siteinspection

  • Maintenance of required regulatory documents, such as the manufacturinglicenses issued by local Health Authorities

  • PostApprovalSubmissions

  • Manage,prepareandreviewregulatorydocumentpackagesforpostapproval


  • Closeinteraction withthe GRA CMC Product Lead for the development of regulatory strategies andglobal regulatory oversight

  • PrepareandassembleCMCcontentforproductannualreports,renewals

  • InterpretationandcommunicationofRegulatoryIntelligence

  • Provideinterpretiveanalysesregardingimpactofcomplexregulatoryguidance


  • Original Submissions

  • Manage,prepareandreviewregulatorydocumentpackagesfororiginal medical device and combination productsubmissionsasassigned

  • Closeinteraction withthe GRA CMC Product Lead for the development of regulatory strategies andglobal regulatory oversight

  • Prepareandassemblecontentforhealth authority inquiries for submissions

  • Lead the preparation formeetings and teleconferences with health authorities

  • Lead regulatory teamsin developing medical device regulatory strategies


Basic Qualifications:

University science degree with 3 - 5 years of medical deviceor combination product regulatory experience.

Knowledge of relevant medical device regulations (FDA, EU,HC, etc.) is essential.

Excellent in English language, including technical writingskills.

Preferred Skills:

  • Proficient in MS Word, Excel, PowerPoint, MS Project,Liquent, and Trackwise.

  • Excellent organizational and communication (written andverbal) skills.

  • Demonstrated ability to work successfully on project teams.

  • RAC certification preferred.

  • Previous experience working in a fast paced environment onmultiple product lines

  • Manufacturing, QA/QC experience #LI-GZ

Job: Regulatory Affairs

Primary Location: United States-Massachusetts-Cambridge (U.S.)

Job Posting: Aug 22, 2016, 8:21:29 AM

Job Type: Regular

Employee Status: Regular