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Seasoned professional with 9+ years in pharmaceutical regulatory operations and affairs, focusing on Regulatory Information Management System implementations. Demonstrated ability to manage complex regulatory data projects and deliver comprehensive regulatory activities for EU and ROW markets. Strong leadership and project management skills, with a commitment to optimizing processes and enhancing team collaboration. Known for analytical thinking and problem-solving capabilities, driving high productivity and efficiency in all tasks.
Driven Lead Associate with excellent task prioritization and customer service skills. Knowledgeable team player with experience. Analytical professional with technical knowledge and critical thinking skills to thrive in data-driven environments. Tackles challenges with positivity and drive to overcome. Works great alone or with others and consistently exceeds expectations.

A Regulatory Submission Manager with extensive expertise in managing, leading, and executing submissions for drug products and medical devices, ensuring strict adherence to project plans and dispatch timelines. Committed to delivering
high-quality results, with full responsibility for document procurement, dossier compilation, publishing, and timely dispatch to Country RA or Health Authority Gateways for direct submissions. Proficient in Regulatory Publishing and Archiving,
utilizing tools such as Liquent Insight Publisher, eCTD Manager, ISI Toolbox, Veeva Vault RIM, and Smart Desk for US, EU, and Emerging Markets in eCTD, NeeS, and Paper formats.

Skilled and experienced regulatory affairs professional with strong expertise in pharmaceutical submission publishing and regulatory compliance with overall 4.6 Years of experience in Regulatory Affairs-Submission Publishing with Comprehensive knowledge of US/ROW markets. proficient in using ORION, RED Compass, and various validation tools (RA-Submission Publishing) and Mentoring activity with Good Hands-on Safety tools. Adept at managing document archiving, regulatory tools,
and ensuring timely, quality submissions in accordance with global standards and internal SOPs.
I Value collaboration, learning, and excellence and eager to contribute to a diverse and dynamic team.



  Over 9 years of professional experience in various areas of clinical publishing, and regulatory operations in the Pharmaceutical and Life science industry.
  Worked as a Team Supervisor at Parexel and lead 12 people in completing the Data Migration project successfully.
  Expertise in creating global regulatory submissions/ in eCTD format for different application types such as IND, NDA/NDS, SNDS, ANDA, BLA, DMF, MAA, AdProm (Advertising Promotional Professional and Consumer, Pre-Clearance) to FDA, and Health Canada.
  Experienced in Next Docs, QUMAS, SharePoint, Liquent Smart Desk product, ISI toolbox and experienced in Document Preparation (Bookmarking and Hyperlinking) on different modules from M1-M5 and performing QC tasks.
  Coordinated the submission of Safety Reports (DSUR, PBRER, PSURs), Annual Reports and ensures timely submissions with original and lifecycle regulatory submissions in eCTD format including technical review of critical components for accuracy, compliance with Health Authority requirements and internal standards.
  Understanding of change control documentation, quality systems, and documents.
  Experienced in working with CSR, DSUR, PSUR, PBRER, Annual Reports, Clinical Trial registrations, and Ensuring compliance with clinical trial registry regulations (design registration and updates) - CT. Gov & ENCEPP
  Working Knowledge and experience for US FDA guidance and ICH guidelines along with Electronic Gateway Submissions.
  Experienced in registering clinical trial information on clinical trial registries (e.g. Clinicaltrial.gov, ENCePP) at the time of working with Novartis and external agency's requirements.
  Quick Learner, the ability to learn new skills and software products that are available in the market, and can work individually and/or in a team with minimum supervision.


Yadnesha Deore

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Lead Associate

Regulatory Document Specialist

Education

Bachelor of Pharmacy -

Higher Secondary Certificate (HSC) -

Secondary School Certificate (SSC) -

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Lead Associate

Regulatory Document Specialist

Bachelor of Pharmacy -

Higher Secondary Certificate (HSC) -

Secondary School Certificate (SSC) -

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