Name

Hyderabad

PROFESSIONAL SUMMARY

Regulatory affairs professional currently working with Global Regulatory Affairs - Labelling department. Experience New product launches, General export packs, Pre and Post Approval Variations, Submissions, Regulatory compliance and acting as proxy for European Regulatory markets for Pharma and Vaccine products, Preparation and review of safety reports.

WORK EXPERIENCE

Senior Associate Analyst
05/2021 - Present
Tech Mahindra, Hi-tech City
Custodian of the packaging design and layout for all products
Provides relevant source data for the Change Order/ Change Awareness notification
Annotate the PDF’s as per the respective Regulatory source content (word format)
Clarify on need basis with the respective stakeholders, i.e., Labelling Lead, Artwork Coordinator, Market or Site
Adherence to GSK artwork production standards and Standard Operating Procedures
Identifies and engages other individuals who need to be involved in the review and approval of a Change Order, in accordance with any local procedures and requirements
Participates in the review of the change on its viability on behalf of the market
For changes initiated by the site: Reviews comments and authorizes the Change if required
Ensures all critical checks have been carried out in accordance with the artwork checklist
Approves the Change, referring to Regulatory Approved Labelling in Country Prescribing Information / Local Datasheet from Regulatory Vault
Reviews and approves the new artwork in the Change Order(s) against Regulatory Approved Labelling in Country Prescribing Information /Local Datasheet and any supporting documents
Responsible to re-prioritise the changes based on the business requirements
Co-ordinates market activities/approvals as necessary throughout the lifetime of the change
Ensure that all design and readability guidelines are adhered to across the full range of packs.
Checks and confirms that artwork created matches authorized briefs / change orders covering multiple types of pack components, languages and formats
To ensure that the relevant markets and sites approve the artworks prior to the Global Labelling approval or where acting on behalf of the LoC approve the change in line with the project and schedule requirements
Adherence to regulatory and quality compliance requirements
Adherence to agreed schedules for artwork production
Be part of weekly Planning meetings to understand upcoming changes
Responsible for working with Leads/Operations Manager to identify issues and resolve accordingly
Responsible for maintaining high standards and working within agreed service level agreements
Ensures that data integrity and accuracy is maintained throughout the proof-reading (review of the artworks) / amendment stages
Implements the principles of Operational Excellence and Lean Sigma to recommend and bring about continuous improvement.
Monitors progress of artwork creation and ensures delays or issues are rectified or escalated to the appropriate level of management, and customers are kept informed of progress

EDUCATION

MBA in Healthcare Management
Btech in Bio-Medical Engineering

SKILLS