Zeba Fatima
Mississauga,ON
Summary
Detail-oriented and highly knowledgeable Pharmacy Regulatory Affairs Associate with over 3 years of experience in ensuring compliance with pharmaceutical regulations and guidelines. Seeking to contribute expertise in regulatory submissions, quality assurance, and product compliance to support the growth and success of a pharmaceutical organization.
Overview
4
4
years of professional experience
Work History
Pharmacy Regulatory Affairs Associate
Cellchem Pharma
11.2021 - Current
- Prepare and submit regulatory documentation to health authorities, including FDA and other regulatory agencies, for new drug applications, amendments, and product lifecycle maintenance
- Collaborate with cross-functional teams, including R&D, quality assurance, and clinical operations, to gather data and information required for regulatory submissions
- Conduct regulatory research to stay current with evolving regulations, guidelines, and industry best practices, ensuring compliance and timely updates to internal stakeholders
- Assist in preparation of responses to health authorities' queries and provide support during regulatory inspections and audits
- Maintain regulatory files, documentation, and databases to ensure accuracy, completeness, and accessibility of records.
- Performed and documented quality control checks to maintain compliance with company initiatives
Regulatory Compliance Specialist
Eytan Pharma
10.2020 - 09.2021
- Supported the regulatory affairs team in the preparation and submission of drug applications, renewals, and variations
- Reviewed product labeling and promotional materials to ensure compliance with applicable regulations and guidelines
- Assisted in internal audits and gap assessments to identify areas for process improvement and compliance enhancement
- Conducted training sessions for employees on regulatory procedures and quality standards.
Pharmacy Technician
Natco Pharma
06.2019 - 08.2020
- Performed medication dispensing and compounding under the supervision of licensed pharmacists
- Maintained accurate and up-to-date patient records, prescription logs, and inventory management
- Provided exceptional customer service and addressed patients' medication-related inquiries
- Assisted in managing pharmacy operations and workflow to ensure efficiency and adherence to regulations.
Education
Bachelor's - Pharmacy
Jawahar Lala Nehru Technological University
HPost Graduate Diploma - Regulatoru Affairs
Algonquin College of Arts And Technology
Skills
- Regulatory Submissions and Compliance
- FDA Regulations and Guidelines
- Quality Assurance and Auditing
- Pharmaceutical Product Lifecycle Management
- Data Analysis and Research
- Document Management and Control
- Cross-functional Collaboration
- Communication and Presentation
- Problem-solving and Decision-making
- Regulatory Adherence
- Pharmacy File keeping
- Regulatory Auditing
- Regulatory Agency Applications
- Directing pharmacy operations
- Retail pharmacy procedure knowledge
Timeline
Pharmacy Regulatory Affairs Associate
Cellchem Pharma
11.2021 - Current
Regulatory Compliance Specialist
Eytan Pharma
10.2020 - 09.2021
Pharmacy Technician
Natco Pharma
06.2019 - 08.2020
Bachelor's - Pharmacy
Jawahar Lala Nehru Technological University
Post Graduate Diploma - Regulatoru Affairs
Algonquin College of Arts And Technology
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