Ismat Farheen Hashmi
Liverpool
Summary
Experienced regulatory intelligence professional with a strong background in medical devices and pharmaceuticals. Proficient in regulatory compliance, dossier preparation, and quality management. Skilled in technical writing and cross-functional collaboration to enhance operational excellence. Committed to leveraging strategic insights to support regulatory submissions and ensure adherence to global standards.
Overview
6
6
years of professional experience
2
2
years of post-secondary education
1
1
Certification
Work history
ASSOCIATE- GLOBAL REGULATORY INTELLIGENCE
Freyr Global Regulatory Solutions Pvt. Ltd
Hyderabad
2023.04 - 2025.09
- Assisted in monitoring regulatory changes for assigned geographical regions and product divisions, including pharmaceuticals, medical devices, and consumer products.
- Supported compilation and maintenance of regulatory intelligence databases for MHRA, EMA, and USFDA compliance.
- Contributed to writing technical summaries and compiling data in predefined templates.
- Helped build tracking and monitoring systems for new or revised regulations.
- Reviewed regulatory intelligence data for relevance and accuracy for client presentations.
- Performed administrative duties to improve operational efficiency.
- Worked on special projects as assigned, ensuring timely completion before deadlines.
- Encouraged positive communication within working environment.
JUNIOR ASSOCIATE- GLOBAL REGULATORY INTELLIGENCE
Freyr Global Regulatory Solutions Pvt. Ltd
Hyderabad, Tameside
2021.04 - 2023.04
- Assisted in developing newsletters for stakeholders and assisted in summarising compliance policies and guidelines.
- Supported regulatory surveillance efforts by identifying changes affecting pharmaceutical and medical device sectors.
- Conducted quality checks on RI data to ensure relevance, accuracy, and suitability.
- Provided technical support for data evaluation and assisted in uploading into product systems.
- Communicated decisions and action items effectively to team members and stakeholders.
- Aided in document preparation and quality control for regulatory submissions.
TRAINEE- MEDICAL DEVICES
Freyr Global Regulatory Solutions Pvt. Ltd
Hyderabad
2019.11 - 2021.04
- Assisted in preparation of regulatory submissions dossiers and DMF documentation.
- Conducted regulatory research to support insights on CE marking, 510(k), and MDR requirements.
- Compiled over 11 regulatory dossiers to aid successful medical device registrations in India.
- Helped prepare technical files and compliance documents for Class I, II, and III medical devices.
- Monitored official regulatory data from databases and tools to ensure compliance.
- Supported preparation of regulatory submission documents for medical device technical files.
Education
Master's in business administration - Management
Bangor University
Bangor, Wales 2025.09 -
Master of Science - Pharm.
National Institute of Pharmaceutical Education And Research (NIPER)
Mohali, Punjab 2017.08 - 2019.07
Skills
- Project Management
- Quality Management
- Data Management & Documentation
- Regulatory Compliance
- Cross-functional Team
- Problem-solving
- Calm under pressure
- Data Operations
- Regulatory Submissions
- Regulatory Intelligence and compliance (EMA, MHRA, USFDA)
- Medical Device Regulations & Technical Files
- Dossier Preparation & Submissions (CTD, DMF, eCTD)
- Client Communication
Certification
- IELTS by IDP (03/2025-03/2027) I have completed my IELTS proficiency test with an overall band of 7.5
- Advanced Diploma in Drug Regulatory Affairs (ADDRA) (02/2025-02/2026) Advanced Diploma in Drug Regulatory Affairs (ADDRA) – Jamia Hamdard University
- Diploma in Project Management (02/2025-02/2026)- Indian Institute of Skill Development & Training (IISDT)
LANGUAGES
English Full Professional Proficiency
Hindi Native or Bilingual Proficiency
Urdu Full Professional Proficiency
Marathi Full Professional Proficiency
Affiliations
- Poetry
- Singing and Performing
Volunteer (Floor Assistant) | British Heart Foundation | Liverpool, UK | [Dec, 2025 – Present]
- Assisted customers on the shop floor, providing product guidance and ensuring a positive shopping experience
- Supported visual merchandising and organisation of donated items to maintain an attractive store layout
- Operated as part of a team to manage stock rotation, sorting, and pricing of donated goods
- Handled customer queries and transactions, developing strong communication and interpersonal skills
- Contributed to fundraising efforts by promoting sales and supporting store operations
Timeline
Master's in business administration - Management
Bangor University
2025.09 -
ASSOCIATE- GLOBAL REGULATORY INTELLIGENCE
Freyr Global Regulatory Solutions Pvt. Ltd
2023.04 - 2025.09
JUNIOR ASSOCIATE- GLOBAL REGULATORY INTELLIGENCE
Freyr Global Regulatory Solutions Pvt. Ltd
2021.04 - 2023.04
TRAINEE- MEDICAL DEVICES
Freyr Global Regulatory Solutions Pvt. Ltd
2019.11 - 2021.04
Master of Science - Pharm.
National Institute of Pharmaceutical Education And Research (NIPER)
2017.08 - 2019.07