Dr. Ambika Choudhary Email & Phone Number

Boston, MA, US

United States

• Spearheaded the creation of a comprehensive Standard Operating Procedure (SOP) for Unique Device Identification (UDI) tailored to Class IIa medical devices in compliance with upcoming EU MDR regulations.
• Facilitated the transition of medical devices from MDD (Medical Devices Directive) to MDR (Medical Devices Regulation), ensuring alignment with enhanced regulatory requirements and maintaining "legacy device" status.
• Applied regulatory knowledge to develop a robust UDI framework, including UDI-DI and UDI-PI components, while ensuring compliance with EUDAMED requirements.

India

• Conducted literature searches, organized data for regulatory submissions and product development, carried out real-world data analysis, authored articles and case reports, producing impactful content and enhancing the.
• Assisted in preparation of regulatory submissions utilizing the eCTD format and preparation of responses to regulatory queries
• Monitoring any changes in local regulatory requirements and communicating it within the department.
• Collaborated closely with physicians to develop original manuscripts intended for publication in scientific journals, ensuring accuracy and adherence to regulatory guidelines.
• Demonstrated strong research skills and attention to detail, contributing to the dissemination of valuable medical knowledge.

Moradabad, Uttar Pradesh, India

• Partnered with critical care physicians to provide patient-centric care, conducting detailed analysis of medication profiles in the ICU.
• Promptly reported cases and actively contributed to dosage optimization strategies, enhancing patient outcomes and safety.
• Demonstrated effective communication skills and the ability to work collaboratively within a multidisciplinary team environment.

India

• Co-developed educational materials in collaboration with Monash University, resulting in a 30% improvement in comprehension rates among participants.
• Facilitated discussions and encouraged critical thinking skills, fostering an engaging learning environment.
• Demonstrated expertise in pharmacology and therapeutics, providing detailed solutions and guidance to enhance student learning experiences.

Hyderabad, Telangana, India

• Enhanced patient-focused outcomes by conducting comprehensive analysis of medication profiles in the ICU, contributing to dosage optimization strategies.
• Collaborated closely with critical care physicians to provide optimal care and support for critically ill patients.
• Demonstrated strong analytical skills and attention to detail in a fast-paced clinical environment.
• Assisted in implementing efficient participant recruitment strategies, resulting in a 20% increase in enrollment rate.
• Aided in IRB submissions, maintain trial related documents and ensured compliance to good clinical practices (GCP).

India

• Provided subject matter expertise and guidance to students in the field of Pharmacology and therapeutics, enhancing their learning experiences.
• Demonstrated strong communication skills and the ability to convey complex concepts in an understandable manner.
• Contributed to the academic success of students by providing detailed solutions and guidance.

Ms Regulatory Affairs, Gpa :3.98

● Recipient of CPS Leaders and Scholars Award. ● Relevant Coursework: Regulatory Compliance Practice, Product Development, and Life Cycle.

Doctor Of Pharmacy - Pharmd, Gpa : 3.62

Activities and Societies: Organizer of Health Education and Awareness camps. Member of Pharmacy Research Club. ● Gold Medalist of Batch.