Bhagyashree Temgire

Performed complete data procurement and entry tasks within Regulatory Information Management (RIMS) and Central Data Provisioning teams to meet client specifications.

Provided extensive RIM data management support as necessary to maintain regulatory standards.

Conducted data entry in RIMS database for registrations, regulatory updates, and changes.

Leveraged systems such as Veeva Vault Sandbox, SharePoint, and PRISM to enhance workflow efficiency.

Oversaw RIM Central Data Service product registrations, focusing on effective data procurement from regulatory sources.

• Coordinated communication between regulatory agencies and internal teams.
• Reviewed regulatory submissions for compliance with industry standards and regulations.
• Prepared documentation for product registrations and license renewals.
• Assisted in developing internal policies to align with regulatory requirements.
• Maintained detailed records of submissions and correspondence with authorities.
• Collaborated with cross-functional teams to ensure timely project completion.
• Organized and submitted company forms and regulatory documents.
• Drafted and reviewed regulatory documents for compliance with international regulations.
• Managed responses from health authorities regarding questions about clinical trial protocols or other submissions made by the company.
• Maintained records according to Good Documentation Practices guidelines.
• Identified areas of non-compliance with relevant regulatory standards and provided corrective actions where necessary.
• Conducted quality control and integrity checks for accuracy within Teva Global Registration database.

Directed large-scale migration of US and international data into Global Insight Publishing Software to meet regulatory needs.

• Applied in-depth knowledge of regulatory dossier structures to enhance registration data management.
• Identified areas of non-compliance and recommended corrective action plans.
• Provided guidance on global registration activities, including but not limited to labeling and advertising materials.

Efficiently prepared and submitted ROW market regulatory documents in a timely manner.

• Assisted in preparing and reviewing regulatory submissions for pharmaceutical products.
• Collaborated with cross-functional teams to support product development initiatives.
• Conducted literature reviews to gather relevant data for research projects.
• Handled stakeholder inquiries, providing relevant information and maintaining transparency.

Collaborated with Packaging, Licensing, Medical, and Manufacturing units to achieve seamless coordination.

• Maintained accurate documentation of project progress and compliance standards.
• Provided administrative support to senior associates and project managers as needed.
• Trained new team members on company policies and operational procedures.
• Maintained accurate records of all trainee activities, including attendance and completion data.