FARWA HAIDER
Hillsborough,NJ
Summary
Regulatory Affairs Specialist with extensive experience in IND lifecycle support and post-approval changes. Expertise in managing protocol amendments, coordinating submissions, and ensuring document compliance across cross-functional teams. Demonstrates strong organizational skills and effective communication to maintain regulatory commitments.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Regulatory Affairs Specialist
Bausch Health
06.2025 - Current
- Support IND regulatory activities including protocol amendments and other filings, coordinating inputs across functions to keep submissions on schedule and compliant.
- Prepare and submit 20+ IND Annual Reports, working with internal stakeholders to confirm completeness, consistency, and readiness for submission.
- Draft and review Non-CMC content for a high-volume portfolio (40 NDA and 17 ANDA Annual Reports), including literature searches to support compliant reporting.
- Support post-approval changes for NDA and ANDA products, helping teams navigate requirements and document updates efficiently.
- Maintain PMR tracking to support audit readiness and timely follow-through on regulatory commitments.
- Compile and submit CARES Act reports by collecting and reconciling distribution/manufacturing inputs across multiple sites.
- Coordinate ANDA labeling updates with the Labeling team to align with RLD requirements and maintain consistency across the portfolio.
- Verify product history and coordinate with Supply Chain and Labeling to complete discontinuation notifications for 20 products.
- Provide safety label change memo updates to Pharmacovigilance to keep post-marketing documentation current and aligned.
Regulatory Affairs Associate
Sun Pharmaceuticals
07.2022 - 06.2024
- Interpreted applicable FDA requirements and internal procedures to support compliant regulatory deliverables.
- Prepared and reviewed labeling, packaging, and promotional materials to ensure accuracy, consistency, and regulatory compliance.
- Coordinated creation and updates of labeling with R&D, QA, Marketing, Medical, Legal, and Artwork teams, managed review cycles and document control.
- Supported label change controls and risk assessments to enable timely approvals and implementation.
- Maintained regulatory documentation and database records to support submission readiness and traceability.
- Supported CMC writing work by drafting/editing ANDA sections and helping assemble response packages under tight timelines.
- Coordinated CMC documentation with internal teams and external partners to meet submission deadlines.
- Contributed to annual reports and post-approval change documentation as part of routine lifecycle maintenance.
Junior Regulatory Affairs Associate
Zydus Pharmaceuticals
06.2020 - 05.2022
- Supported preparation of ANDA and NDA submissions, helping ensure document completeness and compliance with internal standards.
- Participated in execution of regulatory strategy and routine compliance monitoring activities.
- Tracked regulatory guidance updates and summarized relevant changes for internal stakeholders.
- Supported development of labeling plans with cross-functional teams to align requirements and timelines.
- Maintained regulatory documentation and database records to support inspection readiness and accurate tracking.
Education
Doctor of pharmacy - Pharm-D
Riphah Institute of Pharmaceutical Sciences
07-2017
Skills
- Regulatory Activities
- IND lifecycle support
- Protocol amendments
- Green Light Package review
- Post-approval changes
- Change control
- REMS support
- PMR support
- Labeling updates
- Documentation & Compliance
- Regulatory document QC
- Audit-ready file preparation
- Version control
- Tracking
- Familiarity with FDA guidelines
- Familiarity with ICH guidelines
- Cross-Functional Collaboration
- Clinical Operations
- Labeling
- QA
- CMC
- Strong attention to detail
- Organized
- Clear communication
- Professional communication
- Comfortable working with teams
- Good at managing timelines
- Shifting priorities
- Quick learner
- Practical problem-solver
- Reliable
- Ownership of work
Certification
BCMAS – BOARD CERTIFIED MEDICAL AFFAIRS SPECIALIST, 07/01/24, 07/31/29
Cross Functional Collaboration
- Clinical Operations
- Labeling
- QA (previous role)
- CMC
Languages
- English
- French
Documentation Compliance
- Regulatory document QC
- Audit-ready file preparation
- Version control & tracking
- Familiarity with FDA and ICH guidelines
Regulatory Activities
- IND lifecycle support
- Protocol amendments
- Green Light Package review (1572s, PI CVs, site documents)
- Post-approval changes & change control
- REMS and PMR support
- Labeling updates and coordination
Timeline
Senior Regulatory Affairs Specialist
Bausch Health
06.2025 - Current
Regulatory Affairs Associate
Sun Pharmaceuticals
07.2022 - 06.2024
Junior Regulatory Affairs Associate
Zydus Pharmaceuticals
06.2020 - 05.2022
Doctor of pharmacy - Pharm-D
Riphah Institute of Pharmaceutical Sciences