Experience as Analyst Artwork Operations

• Employer

  Novartis Healthcare Pvt Ltd

• From

  10 June 2019

• To

  01 October 2019

• Detail

  • Assist in mass Artwork creation / changes in the day to day environment and support major projects in the Novartis Artwork space.
  • Supports the Manager –Artwork Ops Artwork Specialists for meeting business priorities to ensure timely delivery of the approved artwork, especially for launches, safety-related changes and transfers to guarantee fast and successful implementation of the Novartis Pharma products on the market (avoid stock-out situations).
  • Perform and deliver quality reviews and trends, performance reporting, artworks review and monitoring, audit support and application user support related to Artwork Ops
  • Ensure on time In full delivery of service to internal Artwork customers and stakeholders
  • Accountable for high-quality artworks fully compliant with Novartis standards and in-country regulatory, marketing, manufacturing and legal compliance.
  • TechOps Support, part of the Operations Services Practice (OSP) within Product Lifecycle Services (PLS), delivers a portfolio of services and solutions to manufacturing and supply processes of Novartis, creating value for the internal customers across all Novartis divisions and geographies.
  • Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, SALTO, AQWA etc.) and perform follow-up actions if required.
  • Create and review GxP documents and reports like trend analysis, performance, qualification, validation and technical investigations.
  • Responsible for GMP compliant documentation following external and internal regulatory aspects and processes. Create and review GxP documents and reports like trends, performance, qualification, validation and technical investigations.
  • Ensure adherence to Novartis standards and quality manuals
  • Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
  

Experience as Associate Regulatory Affairs

• Employer

  PAREXEL International

• From

  23 May 2017

• To

  23 May 2019

• Detail

  • For EU - Product lifecycle management. Mutual Recognition Procedure/ National procedures and Co-ordination with CMS countries for MRP Procedure.
  • For US - Supplement filling - Prior Approval Supplement (PAS), Change Being Affected-0 (CBE-0), Change Being Effected-30 (CBE-30) etc.
  • Preparation of submission dossiers for National phase submission in EU.
  • US Annual Report submission on labeling perspective
  • EU Safety Submission (PSUSA/PEBER) on labeling perspective
  • Generating the change control form for Artwork update.
  • Preparing the Mock-up/composition copy to update the artwork.
  • Review and Approval of artwork in systems (GAME and SPS). Liaising with other regions if using shared materials and/or suppliers.
  • Participating in the development of the Company Core Datasheet for Mature product line extensions and the development of prescribing and patient information for local markets
  • Managing core and local prescribing/patient information throughout the product lifecycle
  • Working with colleagues in markets worldwide to ensure implementation of the company core datasheet into local prescribing/patient information
  • Conducting the CFLT meetings and preparation of minutes of meetings
  • Managing documentation to support global and country/regional product information (PI and USPI) development and maintenance.
  

Experience as Executive Regulatory Affairs

• Employer

  iMEDGlobal Solutions India Pvt Ltd

• From

  23 November 2015

• To

  10 May 2017

• Detail

  • Preparation of submission dossiers for National phase submission in EU.
  • For US - Supplement filing - Prior Approval Supplement (PAS), Change Being Affected-0 (CBE-0),
  Change Being Effected-30 (CBE-30), etc.
  • Compilation and review of labeling (CCDS) components.
  • Creation of Implementation tracker, Distribution list and Maintenance of Development Tracker.
  • Sending out CLCN notifications to the markets.
  • Tracking and Monitoring of Company Core Data Sheet.
  • Generation of PSMF Report and Regional Reports.
  • Generation of HA and Local Driven Reports.
  • Sharing of Updated CCDS with Partner Company within Pharmacovigilance Agreement.
  • Preparation of Present and Proposed comparison table for EU region as per QRD Guideline.
  • Manage the preparation and submission of new product registrations and follow-up closely on queries and through approval.
  • Ensure regulatory compliance with local and Regional regulatory requirements.
  • Ensure to adherence to timelines and quality set parameters.