Anjana Sivakumar

A highly motivated Regulatory Affairs professional with strong technical communication skills, seeking a position in the Regulatory Affairs department of a reputed organization where I can make the best of my potential and contribute to the organization's growth.

Submission lead (EU CTR – Initial CTA, transition studies) • Co-ordinating various submissions for Pharma and vaccine assets for Initial CTA as well as transition studies under EU CTR in a timely manner.

• Presenting and leading the Submission Kick off meeting along with Global regulatory lead.
• Defining Global Regulatory Submission strategy within R & D for various initial application and substantial amendment submissions to HA.
• Communication with stakeholders across cross-functional teams such as CMC, Safety, Clinical operations, Scientific writer, Study Delivery lead, Patent Attorney, Non-clinical rep and LOCs/LDLs .
• Procurement of Part I documents and preparing the central package in RIM vault.
• Preparation of Structured Data Map for CTIS. Perform final uploading & submission in CTIS.
• Handling of Request for information (RFI) and HA correspondence. DTA lead • Performed Direct to Agency submission to the respective HA of Ireland, Germany, France and UK.
• Responsible for preparing all the local documents such as Cover letter, SANF, Amendment tool, EudraCT form, IRAS medicines form and submission to HA. RIM lead • Performed end to end activities in Regulatory vault to assist the Submission lead in any CTA/IND submission related activities including creation of DER, content plan, archival of submission package and HA correspondence.
• Also performed tracking of dates and lifecycle changes and crosslinking of documents between clinical vault and regulatory vault.

Graduated with a Masters in Pharmacy degree from a Tier 1 college where I had exposure to latest industry standard courses that have aided me in adapting complex work environments.