Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Rabia Hussain

Carol Stream,IL

Summary

With five years of global regulatory affairs experience in the pharmaceutical industry, I bring exceptional scientific and technical skills to support project management, regulatory affairs, quality assurance, and compliance. My vast knowledge of FDA guidelines and experience with electronic submissions such as eCTD and ESG, as well as IND and NDA regulations, CTA and MAA submissions to EMA, and health, enable me to navigate complex regulatory processes. Additionally, I have extensive expertise in rebranding and labeling procedures. I am experienced in updating SOPs, validation documents, post-approval changes, and qualification reports. My excellent written and verbal communication skills allow me to effectively communicate with individuals at all levels. As an independent professional, I excel both as a team member and a fast learner who easily adapts to new challenges and environments. I thrive under pressure in fast-paced work environments while maintaining precision in my work.

Overview

6
6
years of professional experience

Work History

Regulatory Affairs associate

SIGA Technologies Inc
New York
03.2022 - Current
  • Supported lifecycle and maintenance activities of IND/CTA including amendments, annual reports, DSURs, proprietary name requests.
  • Ensured regulatory alignment by scrutinizing clinical protocols, study reports, Investigator Brochures, and labeling essential for drug development.
  • Managed document workflows using Viva Vault platform.
  • Applies knowledge of key guidance documents, regulations, or directives, and effectively communicates any impact on drug development programs and regulatory filings.
  • Coordinates with cross-functional teams and interfaces with Clinical Operations, Medical Affairs, Technical Operations, and Quality Assurance to define requirements for regulatory submissions.
  • Monitored submissions, assuring they met required standards.

Regulatory Affairs Associate

Romark LLC
Tampa, Florida
05.2019 - 03.2022
  • Contribute to global CMC submission activities (planning, authoring, reviewing, coordination & submission) for assigned projects/products while applying the global strategy into submissions
  • Conduct vigilance assessments on product complaints to support final review from the manager
  • Initiate, investigate & write complaints to assist a busy quality group
  • Create, review and approve label artwork, Label specifications and nonconformance paperwork in a controlled documentation system.

Education

Bachelors in Biological Science -

University of Illinois at Chicago

Skills

  • Product Labeling
  • Pre-market submissions
  • International Regulations
  • Product label creation
  • Data Gathering
  • Document Management
  • Regulatory Submissions
  • Compliance Monitoring
  • FDA regulations
  • Material review
  • Standard Operating Procedures
  • Marketing

References

Available upon request

Timeline

Regulatory Affairs associate

SIGA Technologies Inc
03.2022 - Current

Regulatory Affairs Associate

Romark LLC
05.2019 - 03.2022

Bachelors in Biological Science -

University of Illinois at Chicago
Rabia Hussain