Aastha Bhatt Email & Phone Number

India

Bengaluru, Karnataka, India

• Work with internal and external stakeholders to analyze needs and align delivery roadmap to project goals.• Keep up with agile/scrum best practices and trends• Develop detailed product specifications and ensure they’re clearly understood by the development teams.• Actively mitigate roadblocks impacting successful team completion of release/sprint goals• Serve as the product owner internally and externally, sharing knowledge and answering questions related to the product• Analysis of multiple source systems (CTMS,EDC, IRT, EPRO etc.) for Lifesciences and Pharmaceutical customers and build specifications to align the solutions

Project Title: Regulatory and Quality pathways in India1. Handled four Product Registration to government officials (SUGAM) for Import License Renewals of Cardio Vascular Group.2. Prepared Dossiers and coordinated with multiple business stakeholders ensuring completeness of the application.3. Completed dossier requirement for renewal of 50 product import licenses.4. Internal Quality Audit of government applications and approval status for existing 42 products.5. Labelling and product usage mapping

Vadodara, Gujarat, India

1. Conducted Market Analysis to explore the untapped potential market and Gaps.2. Reviewed and assisted in auditing the technical documents for CE certification in accordance with the latest regulatory guidelines.3. Managed the distributor network overseas and maintained the MIS report.4. Handled Export shipping documents (proforma invoices, custom clearance documents, shipping, and commercial).5. Developed documents for international conference participation and Regulatory registration.

Pgdm, Healthcare Management

Bachelor'S Degree, Biomedical Engineering