ECTD
Shehleeza Imdad
Regulatory Affairs submission Expert
Knittelfeld,Steiermark
Summary
Compilation of technical documents of MDR,IVDR and Pharmaceuticals. I am experienced in Writing clinical evaluation report according to Regulation 2017/745 Annex XIV and In Pharmaceuticals Module V Dossiers. I also worked on Translation of Labels (Use of intend for Patients). Application submissions to AGES for Austrian free sale certificates. I have a direct communication with AGES, QUALITY AUSTRIA and EMA.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs and Quality Assurance Manager
Hycel Handelsges.m.b.h
09.2019 - 02.2021
- Quality Management System Participation in maintaining of Quality Management System Surveillance over documentation of Quality Management System according to ISO 9001:2015 and IS013485:2016
- Regulatory affairs Coordinate with external and internal clients. Coordinate with suppliers Prepare and maintain all the documents according with the new European regulation.
- Preparation of informative materials regarding Hycel products.
- preparation and updating of instructions, labels and lists of products, information for customers about new products and other necessary materials, depending on actual needs directing material to concerned persons.
- Participation in local and international fairs, seminaries and conventions.
- Collecting information regarding offer of competitive organizations.
- Executing duties regarding registration and Free Sale Certificates, in cooperation with other employees.
- Preparation and cataloguing of CE documentation.
- Preparation documentation for distributors.
Executive Regulatory Affair
Wilshire Laboratories (Pvt.) Ltd.
03.2015 - 10.2016
- Compilation of Dossiers of Pharmaceutical & Nutraceutical products by gathering, evaluating, organizing, managing and collating information in a variety of formats.
- Specific focus on stability data and validation reports. Worked with Actd and CTD format according to FDA, ICH and WHO guidelines
- Registration of Nutraceutical products in Myanmar & Cambodia according to guidelines
- Arrange documents such as COPP, Free Sales, GMP & DML certificates.
- PSUR Documentation (non-Clinical trial specifications update, safety reports, stability study (Pre and Post marketing).
- Participate in CAPA management.
- Participation in attaining ISO certificates.
- Participation in the preparation of WHO inspections.
- Proof reading of Artwork and Labeling.
- Co-ordination with importing agents.
- Enhanced regulatory compliance by meticulously reviewing and editing submission documents.
- Collaborated with cross-functional teams for timely and accurate submissions of investigational new drug applications.
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
- Assisted in developing effective strategies for addressing FDA inquiries, leading to faster resolution times.
- Monitored industry trends and regulatory updates, maintaining a strong understanding of current best practices in the field.
- Worked closely with quality assurance teams to identify potential risks and implement corrective actions, ensuring compliance with regulatory requirements at all stages of product development.
Executive Assistant Regulatory Affairs
Ferozsons Laboratories
11.2013 - 12.2014
- Compilation of Dossiers
- Proof reading of Artwork
- Handling Biosimilar/Biotech products dossiers and queries
- Responses to queries raised on submitted Dossiers
- Worked on Analytical Process Validation, Degradation & Bio- equivalence Studies
- Compilation of PSUR reports (non-Clinical trial specifications update, safety reports, stability study (Pre and Post marketing) for dossiers
- Maintained confidentiality with sensitive documents, ensuring proper storage and distribution as needed.
- Provided professional administrative support during board meetings, including agenda preparation and minute-taking duties.
- Collaborated on special projects to improve overall business operations within the organization efficiently.
- Streamlined executive communication by managing emails, phone calls, and scheduling appointments.
- Developed strong relationships with vendors leading to improved contract terms resulting in cost savings for the company.
- Supported executives in decision-making processes by conducting research and presenting findings in clear formats.
- Implemented time-saving solutions that significantly reduced meeting preparation times through efficient resource allocation.
- Improved office efficiency by implementing new filing systems and document management processes.
Regulatory Affairs Officer
Munawar Pharma
06.2013 - 11.2013
- Compilation of Dossiers.
- Arrangement of all required documents.
- Worked on GMP & COPPs documentation.
- Drove continuous improvement in regulatory processes by identifying areas of inefficiency, proposing solutions, and implementing changes that led to measurable improvements in overall performance.
- Consulted with regulatory representatives to manage filings, applications, and reports.
- Developed comprehensive employee training programs focusing on critical aspects of industry regulations, resulting in increased awareness among staff and a strengthened compliance culture.
- Led efforts to obtain necessary certifications for products, allowing for increased market access and revenue growth.
- Reduced response time to regulatory inquiries by establishing a robust tracking system for all incoming communications.
- Ensured high-quality submissions for various product categories through meticulous attention to detail in preparing documents according to agency guidelines.
Education
Blended Quality Management Representative Compact
Blended Quality Management Representative Compact
Vienna-Austria2021
EU Regulatory Affairs
Danube University Krems
Krems-Austria03.2019
Doctor of Pharmacy
The University of Lahore
Lahore-Pakistan2012
Skills
Clinical evaluation report writing (MDR and Pharmaceuticals)
Compilation of technical documents according to regulations of specified country
Quality Standards Determination
Goals Setting
Regulatory Compliance
Quality Systems
Audit Coordination
Documentation Review
Continuous Improvement
Process Development
Document Control
Project Management
Risk Analysis and Mitigation
Work with modified software
Software
Timeline
Regulatory Affairs and Quality Assurance Manager
Hycel Handelsges.m.b.h
09.2019 - 02.2021
Executive Regulatory Affair
Wilshire Laboratories (Pvt.) Ltd.
03.2015 - 10.2016
Executive Assistant Regulatory Affairs
Ferozsons Laboratories
11.2013 - 12.2014
Regulatory Affairs Officer
Munawar Pharma
06.2013 - 11.2013
Blended Quality Management Representative Compact
Blended Quality Management Representative Compact
EU Regulatory Affairs
Danube University Krems
Doctor of Pharmacy
The University of Lahore