Gayatri Kuntamalla
Muscat,Sultanate of Oman
Summary
Professional with extensive knowledge of regulatory and clinical guidelines, including EU MDR/IVDR, ICH-GCP, CIOMS, Indian GCP, and Volume 9A pharmacovigilance standards. Skilled in navigating SFDA and Oman regulatory frameworks, with proven proficiency in Microsoft Office applications. Focused on ensuring compliance with global standards and enhancing healthcare through strict adherence to industry regulations.
Overview
24
24
years of professional experience
3
3
years of post-secondary education
Work history
Medical Devices Regulatory Affairs Specialist
Muscat Pharmacy & Stores LLC
Muscat, Oman
2023.01 - 2026.05
- Assisted in managing medical device and IVD listings for MOH clearance approvals, ensuring compliance with industry standards.
- Supported registration process of medical devices and IVDs with local authorities.
- Executed device vigilance protocols, including timely reporting of field safety notices, product complaints, and recalls to regulatory bodies.
Pharmaceuticals Regulatory Affairs, Product Recall & Quality complaint Coordinator
Muscat Pharmacy & Stores LLC
Muscat, Oman
2017.04 - 2022.12
- Assisted in maintaining communication with principal companies regarding regulatory guidelines from local health authorities.
- Supported review of eCTD dossiers and submissions to local authorities for registration.
- Facilitated quality complaint investigations ensuring effective issue resolution.
- Helped coordinate product recall procedures including notifications and reporting to regulatory bodies.
- Aided in developing and upholding standard operating procedures (SOPs) for regulatory and quality activities.
- Contributed to internal audits verifying compliance with quality systems and regulatory standards.
- Collaborated with teams to evaluate regulatory impacts of product modifications.
- Assisted in assessing compliance of promotional materials and advertising content.
- Provided updates on regulatory intelligence to keep teams informed of industry changes.
- Supported coordination of regulatory submissions ensuring compliance with MOH-Oman regulations.
MOH Sales Coordinator
Muscat Pharmacy & Stores LLC
Muscat, Oman
2012.04 - 2017.03
- Processed customer orders and managed order transactions for timely deliveries.
- Coordinated with principals to obtain quotations and shipping documents.
- Supported sales team by tracking leads and ensuring follow-up for customer conversion.
- Organised team schedules for meetings and training to enhance productivity.
- Assisted in developing sales strategies and setting goals for team.
- Maintained knowledge of products and services to aid sales efforts.
- Prepared sales reports to identify trends and suggest improvements.
- Communicated between sales, marketing, and customer service to ensure alignment.
- Addressed customer inquiries and resolved issues to uphold satisfaction levels.
- Managed inventory and placed orders to guarantee product availability.
- Aided in creating sales presentations and materials for team use.
- Monitored competitor activities to provide insights for strategic planning.
Pharmacovigilance/Drug Safety Associate (Case Processor)
Tech Mahindra (Formerly known as Mahindra Satyam BPO)
Hyderabad, India
2009.11 - 2011.12
- Assisted in reviewing and assessing adverse event reports.
- Supported triage processes in accordance with regulations and guidelines.
- Helped maintain records of individual case safety reports.
- Entered data into safety databases accurately.
- Collaborated with healthcare professionals to gather additional information on reported events.
- Performed initial triage of cases to identify urgency and required actions.
- Contributed to preparation of periodic safety update reports for submissions.
- Participated in safety signal detection activities.
Clinical Research Co-ordinator
Global Clinical Research Services (GCRS), Global Hospitals
Hyderabad, India
2008.09 - 2009.11
- Assisted in coordination of clinical trials for Orthopedic, Pulmonology, and diabetic studies.
- Supported recruitment and screening of study participants with adherence to ethical standards.
- Aided in coordinating with investigators and healthcare professionals for study procedures.
- Managed data entry and validation to uphold accuracy of clinical data.
- Monitored patient health and safety, promptly reporting any adverse events.
- Prepared regulatory documents for audits and inspections.
- Trained research assistants on study protocols and procedures.
- Facilitated communication between research teams and ethics committees.
- Organised study materials including Investigational products and equipment.
- Conducted literature reviews and helped prepare study reports.
Community Pharmacist
J Watumull Global Hospital & Research Center
Mt Abu, India
2002.10 - 2006.10
- Dispensed prescription medicines to customers.
- Checked dosage and ensured that medicines were correctly and safely supplied and labelled.
- Assisted patients with medication counselling and education on proper drug usage.
- Managed inventory and ordered pharmaceutical supplies to maintain stock levels.
- Ensured pharmacy compliance with federal and state regulations and laws.
- Collaborated with healthcare providers to enhance patient care and treatment plans.
- Supported pharmacy technicians and staff to deliver quality service.
Education
Post Graduate Diploma - Clinical Research
ICRI, Bangalore
Bangalore, IndiaPost Graduate Diploma - Pharmaco-Informatics
Bio-Informatics of India, Noida
Noida, IndiaBachelor of Pharmacy - Pharmacy
JNTU, Hyderabad, AP
Hyderabad, AP, India 1998.03 - 2001.08
Skills
- EU MDR/IVDR guidelines
- ICH-GCP guidelines
- CIOMS guidelines
- Indian GCP
- Volume 9A pharmacovigilance guidelines
- SFDA and Oman regulatory guidelines
- Microsoft Office applications
- Communication skills
LANGUAGES
English
Hindi
Telugu
Timeline
Medical Devices Regulatory Affairs Specialist
Muscat Pharmacy & Stores LLC
2023.01 - 2026.05
Pharmaceuticals Regulatory Affairs, Product Recall & Quality complaint Coordinator
Muscat Pharmacy & Stores LLC
2017.04 - 2022.12
MOH Sales Coordinator
Muscat Pharmacy & Stores LLC
2012.04 - 2017.03
Pharmacovigilance/Drug Safety Associate (Case Processor)
Tech Mahindra (Formerly known as Mahindra Satyam BPO)
2009.11 - 2011.12
Clinical Research Co-ordinator
Global Clinical Research Services (GCRS), Global Hospitals
2008.09 - 2009.11
Community Pharmacist
J Watumull Global Hospital & Research Center
2002.10 - 2006.10
Bachelor of Pharmacy - Pharmacy
JNTU, Hyderabad, AP
1998.03 - 2001.08
Post Graduate Diploma - Pharmaco-Informatics
Bio-Informatics of India, Noida
Post Graduate Diploma - Clinical Research
ICRI, Bangalore