RAMYA DEJAPPA

-Responsible for the review, compilation, and submission of registration dossiers including new applications, minor variations, and renewals for conventional medicines, GSL, herbal products, and medical devices to MOHAP and -Dubai Municipality, as well as veterinary products to MOCCAE.

-Coordinate with regulatory authorities throughout the submission review process, ensuring prompt and accurate responses to queries and requests to expedite product approvals.

-Manage the full product lifecycle, ensuring regulatory compliance throughout.

-Oversee the review and submission of new registrations and minor variations for manufacturing sites to MOHAP and MOCCAE.

-Handle import permit applications for veterinary and pharmaceutical products to MOHAP and MOCCAE, particularly when samples are required by quality control laboratories.

-Collaborate cross-functionally with Pharmacovigilance and Quality Assurance teams to maintain regulatory and compliance standards.

-Prepare and maintain weekly reports and regulatory data summaries to monitor the status of renewals and variations.

-Conduct comprehensive reviews of eCTD and dossiers for all products prior to submission.

-Lead meetings with principal companies to discuss product portfolios and regulatory strategies.

-Preparing compiling, and submitting regulatory documents such as product registrations, license renewals, variations, and other submissions required by regulatory authorities (Dubai Municipality and MOHAP).

-Manage the registration and licensing processes for new products or modifications to existing products, ensuring all necessary approvals are obtained before market launch.

-Managing DDC and EBP status and renewals of the company products.

-Assisting in preparing and participating in regulatory audits and inspections by authorities, ensuring all required documentation and processes are in place.

-Providing company products training to all the Team members.

-Ensuring all products and processes comply with relevant UAE regulations, standards, and guidelines set by authorities such as the Ministry of Health and Prevention (MOHAP).

-Dispensed medications accurately according to physician prescriptions.

-Communicated effectively with patients, offering clear guidance on dosage, usage, and potential side effects.

-Maintained comprehensive records of patient history and controlled substance activities.

-Facilitated insurance approval processes for prescribed medications.

-Supported administrative operations as required to ensure smooth workflow

-As a back-up lead, ensured timely completion of the deliverable (interim analysis) by completing all the related tasks i.e., regular check of reported events, review of reports and other adhoc requirements.

-Performed pharmacovigilance activities per project requirement but not limited to review of Safety Event Notification Report (SENR), case processing (AEs, SAEs, UADEs) including case entry, complaint processing (DDs, ADEs, SADEs, OPIs) and raising queries for discrepant data.

-Source documents review for completeness and to identify potential product complaints.

-Narrative writing and dossier preparation for CEC adjudication and end point assessment.

-Perform Quality Check (QC) for pharmacovigilance activities.

-Working knowledge and generation of regulatory reports for submission to regulatory authorities (RA).

-Attended client calls with the safety counterparts and other cross-functional teams and presented safety data.

-Proactively mentored team members by providing an oversight of the workflow processes and also conducted training sessions for the new employees.