Sanofi Recruitment 2021.Sanofi Notification full detailes below.Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
Important Vacancy details:
- Post Name: Officer
- Education: Graduate/Post Graduate
- Experienced:1 to 6 years
- Location:Hyderabad
- Salary:NA
- Openings: NA
Job Description: Hiring For Officer in Sanofi!
[Authoring of dossiers andPreparation of queryresponse,Databaseupdate, Working one‐tools]
- Authoringandreviewingofdossier:Ensurethatalldatasupplied to theaffiliates/regulatoryauthoritiesareof the highest quality possible interms of both content and presentation, whilst meeting agreed deadlines.
- Workproactivelywithinternalstakeholders to ensureprojectneedsaremetcompliantlywithinagreedtimelines
- Assistandprovidesupportin the preparation,distributionandfollowupofregistrationdocumentationrequired to affiliates/ regulatory authorities
- Proper utilization of regulatorye‐tools
- Provide support transversally
- Maintain and update all the relevant databasesup‐to‐date including Post License commitments
- Review of artworks as per the labeling requirements
[Self‐Development andOtherexpectations]
- ParticipatesandCoordinatewithcrossfunctionalteamsforgatheringtherequiredinformation/documentsrequired for authoring thedossiers and query response.
- SupportsSiteRSO/RPMswithregard Regulatory Gap assessments
- Supports Site projectteamsandexternalstakeholders as partof project execution
- EnsureclosecollaborationwithQualityandProcessImprovementteams to ensureoptimalprocessesandtoolsaredevelopedandimplemented.LeadcreationandrevisionofrelevantSOPsandworkinstructions. Evaluate and improveprocessesforsubmissionsand regulatoryinformation
- Understanding ofChange controls.
- Act as a Teammember
- Active participation in meeting the targets
- To update the knowledge from time to time for effective delivery
- Follow up with cross functional teams, ensure the target timelines are met.
- Handle requests, either internal or external, related to RA activities.
[Transversal Cooperation]
- Health Authority (HA), Commitments & Documents: Responsible for arranging timely and accurate tracking of regulatory authority requests and commitments related to approvals.
- Inspection Preparation/Support and timely submission of CAPA and other submissions related to Regulatory compliance.
- To actively involve in understanding and submission of various applications to CDSCO (in SUGAM) and SLA (ODLS) websites.
[Knowledge, Skills & Competencies / Language]
- Ability to work in the teams
- Demonstratedcapacitytotake up additionaltasks
- Excellentcommunicationand CTD writing skills
- Knowledge ofRegulatory guidance
- English proficiency, both oraland written
- Multi‐tasking ability
- Candidate should have excellentinterpersonal skills, be a self‐driven proactive individual with skills inorganization, building working relationships and communication.
- Basic software knowledge (Microsoft windows etc.) is must
[Qualifications]
- Graduate/Post Graduate in Lifesciences
- Minimum1‐6years’experiencewithinRegulatoryAffairsorinsimilarfunctionintheVaccineor Biological industrywith CMCandIndustrialOperationsexperience is preferred
- Demonstrated experiencesin international and local regulatoryaffairs on Vaccines or Biological products
[Requirements of the job]
- This position requiresthoroughknowledge onVaccinesmanufacturing.
- This position requires the incumbent to be proactive in meetingthe organization needs
- Thispositionwillsuit an individualwhoisable to operate with discretionandconfidentialityaboutsensitive data
- To comply withHSE compliance and Business Ethicsthroughout the job
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online
