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Operations - Regulatory Operations Senior Analyst
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Regulatory Operations Senior Analyst
Miejsce pracy: Warszawa
What will you do?Accenture’s Accelerated R&D Services (ARDS) bring a fully integrated, robust business service that delivers enhanced processes across the Clinical, Regulatory and Pharmacovigilance functions around the globe. Mostly, you will be:
Coordinate submission documentation (new and lifecycle submissions). Leverage publishing team as appropriate.
Review and validate submission technical.
Coordinate final submission review and approval by appropriate stakeholders.
Finalize and dispatch submission to client affiliates or Health Authorities as required.
Create and maintain initial and lifecycle events in regulatory information management (RIM) system.
What we expect from you:
Experience in publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (NDA, MAA, NDS, MAA, 510k) to Health Authorities in eCTD, NeeS, eSub or paper formats.
Knowledge of regulatory submission requirements and understanding of the nuances of different submission components.
Experience with publishing software and tools used throughout the pharmaceutical industry and in regulatory information management (RIM) systems.
Minimum 2 years of experience in an area of expertise (e.g., regulatory documentation publishing, RIM data management).
Knowledge in handling registrations and maintenance of pharmaceutical products from a regional or local perspective.
What we can offer:
Support for your career and competences development – learning from colleagues, courses and trainings, allowing you to boost your skills and become #BEFUTUREPROOF
Using foreign language and new technology solutions daily, cooperating with various Clients
CSR activities and rich social life – Book Club, International Cuisine Club, Accenture Runners Club, family events, cultural meetings, photography classes, climbing, soccer, swimming
Full work comfort – private medical care, life insurance, access to MyBenefit platform
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"I hereby express my consent to process my personal data included in my job offer by Accenture Sp. z o.o. or any other entity of the Accenture group for recruitment purposes and once the recruitment process is closed, I agree that Accenture Sp. z o.o. with its registered seat in Warsaw, 00-121, ul. Sienna 39 or any other entity of Accenture group places and processes my personal data in its database. I also express my consent to sending my personal data to third parties within the Accenture group pursuant to the Personal Data Protection Act of 29th August 1997 (Journal of Laws of 2002, No. 101, position 926 as amended). I submit the data voluntarily. I have been informed about the right of access to the content of my data and about the possibility of correcting them."
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