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    Job · 10901138

    Accenture logo

    LifeScience Regulatory Svs Manager

    Accenture · Bengaluru · onsite · Posted 71d ago

    Undisclosed13–18 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role


    Skill required: Regulatory Services - Life Sciences Regulatory Affairs

    Designation: LifeScience Regulatory Svs Manager

    Qualifications:MSc

    Years of Experience:13 to 18 years

    What would you do
  1. You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world¢-
  2. s leading biopharma companies bring their vision to life ¢-- enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
    Regulatory Services involves helping organizations comply with laws and regulations. This role includes providing guidance on regulatory requirements, preparing necessary documentation, and submitting reports to regulatory authorities. It also involves staying updated on regulatory changes and conducting compliance audits. The goal is to ensure the organization meets all legal and regulatory obligations efficiently.
    Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc.

    What are we looking for
  3. Adaptable and flexible
  4. Ability to perform under pressure
  5. Problem-solving skills
  6. Detail orientation
  7. Ability to establish strong client relationship

    Roles and Responsibilities:
  8. Gather, review, analyze, and evaluate pertinent data to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: clinical study reports (CSRs), patient narratives, protocols, investigator-s brochures, CTD Modules, DSURs, PBRERs, PADERs, etc. The tasks, to a large extent, will have to be performed independently.

    Qualification MSc
  9. Sourced from naukri

    Skills

    pharmacovigilanceclinical trialsregulatory changesRegulatory AffairsauditsPatient ServicesResearchoperationsclient relationshipBrochuresLegalcomplianceLife Sciences

    About Accenture

    Accenture logo

    Accenture

    IT Services & Consulting

    350k+

    employees

    1989

    37 years old

    Dublin

    Ireland

    About

    Accenture plc is an Irish-American, professional services company based in Dublin, specializing in information technology services and consulting.

    Industries

    IT Services & ConsultingAnalytics & KPOSoftware ProductManagement Consulting

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