Priyanka Ramesh Shende

• Responsible for Post approval Labelling and CMC changes – EU, US and Canada.
  End to end work on Labelling submissions for Canada (artworks creation, maintenance in Oneart and Agile, review of documents in TVT)
  Led global coordination of label changes, ensuring alignment with evolving regional and international regulations being SME.
  Coordinated global labeling initiatives, including authoring, updating, and aligning Core Data Sheet (CDS) with EU SmPC and US PI.
  Collaborated with RA, QA, Supply Chain, and regional affiliates to streamline labeling workflows and resolve issues proactively.
  Conducted critical reviews of technical artwork and translations, supporting regulatory submission accuracy.
  Mentored junior associates, fostering high-performance culture focused on excellence, ownership, and continuous learning.
  Handled product life cycle management for Global markets and responsible for preparation, compilation, and submission of post-approval quality and labeling regulatory submissions mainly in Europe (all types of variations including workshare and super grouping and for Canada (Annual notification, SNDS, annual report for biologics)
  Compiled and reviewed DSUR, PADERs and PBRER 's
  Maintained regulatory compliance into Regulatory Information Management System (RIM) (e.g DRAGON)
  Provided support as needed for routine Health Authority (HA) submissions including Annual Reports, New Protocol Submissions, Protocol Amendment and as applicable act as main liaison from the DU (development unit)/LCM (life cycle management) with RA Operations to ensure accurate and timely submissions to HAs.

Supported regulatory labeling updates across multiple geographies (US and Canada)
Troubleshoot system and documentation errors, contributing to operational stability and submission accuracy using TVT tool and manual check.
Maintained audit-ready documentation and contributed to inspection preparation activities
Prepared Annual Report packages for various Dosage Forms marketed in US for maintenance and keep track of post approval changes
Accountable for Regulatory Affairs Assessment of any kind of post approval changes for various Dosage Forms (including Drug Substance supplier related changes) marketed for EU and International Markets to maintain the product life cycle management in the market and market strategic planning for submissions to have effective implementation plans
Responsible for Preparation of Post approval Submission packages for Europe and other international Markets
Compiled and submitted labeling changes involving Level I & Level II changes to Health Canada
Responsible for Compilation of labelling documents to be in line with RLD update for US Market
Responsible for Preparation of response to deficiencies raised by regulatory agencies such as Health Canada in accordance with the agency timelines.

• Responsible for Initial submissions of ROW Markets- LATAM/CAR) (Responsible for Global submissions for Post approval changes- US & CA )
• Accountable for regulatory submissions to the health authorities of various countries such as US, CA and ROW
• Compilation and submission of Annual Reports for US market and compilation of post approval submission such as CBE 30 for US market
• Compilation and submission of Annual Notifications and SANDS to Health Canada
• Compilation of submission packages on post approval changes for various ROW Markets and preparation of Annual Product Quality Review document
• Involved in the preparation of regulatory strategy, inputs and planning of submissions and to ensure that the technical documents are generated according to the current regulatory requirements
• Preparation of response to deficiencies and screening clarification requests raised by regulatory authorities in accordance with the agency timelines
• Implement strategies to ensure timely project requirements and completion of Change control RA assessments and SDC Pre-assessments for all markets
• Applying for legal documents like Certificates of Pharmaceutical Products
• Accountable for preparation of documents, submissions with concerned stakeholders, management and identifying, assessing as per country specific requirements to maintain product life cycle management in market and market strategic planning for submissions
• TYPES OF SUBMISSIONS WORKED ON:
• US Market: CBE-30, CBE-0 labelling for RLD Updates mainly, Annual reports, PADERs and provided support in compilation of PAS submission
• CA: SNDS, SANDS, Annual Report for Biologics and Notifiable changes for CMC changes
• CA: Labelling supplements such as SNDS, SANDS and Notifiable changes
• CA: Foreign action Notifications
• CA: Preparation of screening deficiency responses to Health Canada
• EU: Prepared Module 3 documents for post approval submissions Type IA and Type IB, Type II
• EU: Prepared Module 1 documents for post approval submissions Type IA and Type IB, Type II, Type IAin
• EU: Prepared PSUR and worked on EU renewal for CP procedure
• ROW: MOH Notifications, deficiency responses and Renewals.