DR. SHAZIA ABDUL ZEBA
Brookfield,WI
Summary
Motivated Regulatory Affairs Associate with 4+ years of experience. Skilled at developing regulatory strategies and ensuring compliance to applicable standards and regulations, including FDA, EU & ICH requirements. Excels in document management and cross-functional collaboration, demonstrating a keen understanding of medical terminology.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Associate
Eisai Pharmaceuticals
2021.01 - 2023.08
- Developed and implemented regulatory strategies to ensure compliance with applicable regulations and standards
- Responsible for preparation and submission of NDA/ANDA/BLA as per US FDA guidance and checklists.
- Create, review, and approve ANDA and DMFs, Stability Protocols and nonconformance and response to FDA.
- Assembled quality documents related to Prior Approval Supplements, CBE-0 and CBE-30 and Annual Reports.
- Assessed change controls and prepared submissions for ANDA from the change control process.
- Working knowledge of chemistry/biotechnology, analytics and pharmaceutical technology. Knowledge of the drug development process.
- Compilation of DMFs, NDA, and ANDA CMC Sections.
- Assisted in submission of IND and NDA for Trans-thermal products.
- Write work instructions, release SOPs, and create forms to establish quality documentation.
- Assessed change controls and prepared submissions for ANDA from the change control process.
- Prepared submission of new drug applications for approvals to FDA standards & regulatory guidelines
- Assemble documents to submit changes to approved Dossiers of NDAs and ANDAs.
- Design produce and coordinate updates to user manuals and labels to support product improvements, packaging and validation constraints and meet regulatory timelines.
- Assisted in the preparation of regulatory filings for new products
- Collaborate with QA and Analytical department and write work instructions, release SOPs, and create forms to establish and track quality documents.
- Organized and ran cross-functional meetings to plan regulatory strategy for upcoming submissions.
- Worked closely with the pharmacovigilance department in drafting quarterly and annual PADERs.
- Maintained up-to-date knowledge of FDA standards and data requirements for different submissions.
- Participated in the review of product labeling and promotional materials
Regulatory Affairs Associate
Teikoku Pharma
2019.01 - 2020.09
- Create, review, and approve ANDA and DMFs, Stability Protocols and nonconformance and response to FDA
- Worked on CTA Application, IND Annual Reports and reviewed Clinical Trail Protocols and IBs
- Did Technical writing of CMC sections on BLA and Orphan Drugs Applications
- Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies to ensure compliance with applicable regulations
- Write work instructions, release SOPs, and create forms to establish quality documentation
- Assessed change controls and prepared submissions for ANDA from the change control process
- Working knowledge of chemistry/biotechnology, analytics, and pharmaceutical technology. Knowledge of the drug development process
- Compilation of DMFs and ANDA CMC Sections
- Implemented regulatory strategies and solutions to assure all advertising and promotional materials are compliance with regulatory requirements and company policies
- Coordinated the preparation of regulatory submissions and tracked their status
- Developed and maintained regulatory databases and tracking systems
- Prioritized project-related tasks to efficiently complete essential tasks.
General Physician
Owaisi Hospital
2017.08 - 2018.09
- Maintain detailed and accurate patient records, documenting all patient encounters, treatments prescribed, and other relevant health data
- Work with other healthcare professionals, such as nurses, pharmacists, and specialists, to provide comprehensive care. This may involve referring patients to specialists when appropriate.
- Conduct physical examinations and specialized assessments relevant to their area of practice (e.g., neurological exams in neurology, or stress tests in cardiology).
- Managed caseload of 30-40 inpatients, providing health education, treatments, IV therapy, venipuncture, wound care, and other clinical procedures.
- Assisted in major surgeries and performed minor OT procedures and responsible for supervising the cardiac ward.
- Performed Electrocardiograms, 2D-ECHO, and stress tests to monitor the patient’s heart health and identify any abnormalities.
- Presented seminars educating fellow colleagues and the community in promoting health.
- Demonstrated ability to work in a high patient volume area and collaborate with a multi-healthcare professional team.
- Worked closely with the Cardiologist, Neurologist and other medical staff to ensure the best possible
- Monitored post-operative recovery and educated patients on at-home recovery.
Education
Bachelor of Science - Medical Sciences
DR.NTR UNIVERSITY OF HEALTH AND SCEINCES
HYDERABAD03.2018
Skills
- Deep understanding of regulatory guidelines and laws (FDA, EMA, ICH guidelines) relevant to the development, approval, and post-market surveillance of products.
- Familiarity with the regulatory submission processes, including IND, NDA, ANDA, 510(k), PMA, and CE marking applications.
- preparation and submission of documentation for the approval of new products, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Medical Device 510(k) submissions.
- Knowledge of requirements for post-marketing activities, including adverse event reporting, Periodic Safety Update Reports (PSURs), and post-marketing studies.
- MedRA coding and WHOed coding
- Medical terminology, Medical monitoring
Certification
- Certification in Clinical Investigator Training course (CITC), US FOOD DRUG ADMINISTRATION(US-FDA) Dec 2023.
- FDA DRUG TOPICS: AN OVERVIEW OF FDA’S PROJECT FACILITATE ONCOLOGY EXPANDED ACCESS PROGRAM.
- Advanced Certified Course in Clinical Research & Pharmacovigilance, Gratisol Labs
- Basic Life Support (BLS) Certification.
- Advanced Cardiac Life Support (ACLS) Certification.
- INDIAN MEDICAL LICENSURE(2018)
PUBLICATION
Antibiotics as means of secondary prevention of coronary artery disease
Timeline
Regulatory Affairs Associate
Eisai Pharmaceuticals
2021.01 - 2023.08
Regulatory Affairs Associate
Teikoku Pharma
2019.01 - 2020.09
General Physician
Owaisi Hospital
2017.08 - 2018.09
Bachelor of Science - Medical Sciences
DR.NTR UNIVERSITY OF HEALTH AND SCEINCES
- Certification in Clinical Investigator Training course (CITC), US FOOD DRUG ADMINISTRATION(US-FDA) Dec 2023.
- FDA DRUG TOPICS: AN OVERVIEW OF FDA’S PROJECT FACILITATE ONCOLOGY EXPANDED ACCESS PROGRAM.
- Advanced Certified Course in Clinical Research & Pharmacovigilance, Gratisol Labs
- Basic Life Support (BLS) Certification.
- Advanced Cardiac Life Support (ACLS) Certification.
- INDIAN MEDICAL LICENSURE(2018)
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