LifeScience Regulatory Svs Assoc Manager
Accenture · Bengaluru · onsite · Posted 59d ago
Undisclosed10–14 yrsfulltimeSourced from
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 Assoc Manager
Qualifications:Master of Pharmacy
Years of Experience:10 to 14 years
What would you do
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
Roles and Responsibilities: 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 Master of Pharmacy
Sourced from naukri
Skills
pharmacovigilanceclinical trialsregulatory changesRegulatory AffairsrPharmacyResearchclient relationshipLegalcomplianceLife Sciences
About Accenture
Accenture
IT Services & Consulting
350k+
employees
1989
37 years old
Dublin
Ireland
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Accenture plc is an Irish-American, professional services company based in Dublin, specializing in information technology services and consulting.
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