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    Senior Manager Regulatory Affairs - Mumbai, India - Lifelancer

    Lifelancer
    Lifelancer Mumbai, India

    1 week ago

    Default job background
    Description

    About therole:

    Reportingto the Head of Regulatory Affairs you will be a key member of theteam which is responsible for providing strategic and operationalregulatory support to project management on new divestment projectstechnical transfer CMOs quality assurance and commercialdepartments. Our Regulatory Affairs Department has an ethos ofcontinuous improvement refining systems and creating efficiencies.This along with the rapid growth of the business leads to a variedand dynamic working environment.
    Mainresponsibilitiesduties:

    • Leads thepreparation of core dossiers and submissions for global rollout
    • Compile submission documents including M3dossier sections as necessary justification documents and ProductInformation.
    • In collaboration with globalpartners consultancies and distributors outline global regulatoryintelligence and form a global regulatorystrategy
    • In collaboration with seniormanagement and project strategy teams develop and review globalcross functional regulatory strategies
    • Ensurediligent reporting and progress updates on regulatory workload atweekly/biweekly internal regulatorymeeting
    • Interpret applicable regulations andguidelines for project team use; keep project team abreast ofregulatory decisions evolving regulatory requirements risks andmitigation plans
    • Serve as a primary contact tothe local health authority (HA(s) local consultancies/ distributorsand internal stakeholders to ensure timely and accuratesubmissions
    • Facilitate communication betweenthe HA(s) and the project team; attend and generally lead agencymeetings if required
    • Coordinate and solicitcomponents of the submission from various functional areasdistributors and CMOs
    • Proactively identifyproject issues to the project team and support mitigationplans
    • Attend cross functional meetings vendormeetings and kickoff meetings asrequired
    • Mentor and/or manage other RegulatoryManagers Regulatory Associates and other junior level oradministrative Regulatory staff
    • Maintain a highlevel of professional expertise through familiarity with scientificliterature and participation in trainingcourses
    • Other responsibilities may includetraining employees; planning assigning and overseeing regulatorysubmissions

    Aboutyou:

    Candidateswith at least five years of regulatory generalist experience withina pharmaceutical company CRO CMO or similar organization are likelyto have the skills required to be successful in thisrole.

    Weare also lookingfor:

    • Bachelors degreein science/health discipline
    • Great IT skillsincluding MS Word Excel Project PowerPoint andOutlook
    • Expertise in regulatory submissionstructure and content (e.g. MAA NDA)
    • Expertisein artwork requirements and review in line withregulations
    • Strong knowledge of EU regulatoryframework and guidelines
    • Experience incompliance and maintaining product life cycle databases and RIMssystems
    • Ability to effectively communicate withregulatory authorities
    • Ability to independentlypresent complex regulatory strategies with internal stakeholdersand partners
    • Awareness of emerging marketssubmission rollouts
    • Expertise in writingscientific and technical documents and strong attention to detailwith proofreading materials
    • Excellent timemanagement skills with demonstrated ability to juggle multiplecompeting tasks and demands
    • Strongorganizational skills to establish priorities including schedulingand meeting deadlines
    • Ability to worksuccessfully within crossfunctionalteams
    • Excellent professional communicationskills both written and verbal
    • Fluent Englishlanguage (written and verbal) is required and another languagewould be an advantage.

    Please use thebelow link for job application and quickerresponse.

    RemoteWork :

    No

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