Summary
Overview
Work History
Education
Skills
Timeline
Hi, I’m

Sabha Fatima

Naperville,IL

Summary

Regulatory affairs professional with comprehensive experience in regulatory strategy, compliance, and submission processes. Strong focus on collaborative teamwork and consistently achieving results. Adept at navigating complex regulatory environments, ensuring adherence to guidelines, and maintaining up-to-date knowledge of industry standards. Reliable and adaptable, excelling in high-stakes situations and committed to delivering impactful outcomes.

Overview

5
years of professional experience

Work History

Moderna, Inc

Senior Global Regulatory Affairs Consultant
10.2023 - Current

Job overview

  • Oversees the strategical planning and tracking of global regulatory submissions for INDs, BLAs, NDAs and MAA
  • Execute post-approval changes and managed Annual reports such as DSUR, and PSUR, meeting all regulatory requirements
  • Act as a process SME in reviewing/approving the SOP(s) in Veeva
  • As a regulatory CMC, represent the regulatory team in CMC and cross-functional forums
  • Assist in establishing global regulatory strategies to obtain regulatory approvals for existing products
  • Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from Health Agencies
  • Support product lifecycle management activities in Veeva
  • Ensure regulatory CMC requirements are met along the assigned project development work
  • Maintain dossier documentation in the Document Management System (DMS), ensuring timely updates and notifications to Health Authorities (HA) of any changes.
  • Collaborate with cross-functional teams to gather new information related to manufacturing processes, stability testing, and facility updates, ensuring stakeholders remained informed and aligned
  • Represent as a regulatory contact on cross-functional project teams of both internal and external ones.
  • Work with QA/QC teams to ensure the on-time Change Control Closure
  • Coordinate with R&D, manufacturing, regulatory affairs, and other departments to ensure that CMC aspects are addressed throughout the product lifecycle
  • Contribute insights and recommendations to CMC change control guideline and regulation reviews
  • Implement continuous improvement initiatives to streamline sourcing processes, enhance efficiency, and drive operational excellence. Leverage data analytics and performance metrics to monitor Change Control process and identify areas for improvement
  • Supported successful product launches by meticulously preparing submission dossiers and securing timely approvals from authorities.
  • Managed complex regulatory projects, consistently meeting critical deadlines and budget constraints.
  • Maintained and archived regulatory paperwork.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Spearheaded the development of strategic plans, ensuring alignment between short-term tactics and long-term goals.
  • Enhanced regulatory compliance by developing and implementing effective policies and procedures.

BioGen

Regulatory Affairs Manager
02.2023 - 05.2023

Job overview

  • Managed RIM system for streamlined product development and registration
  • Handled Health Authority queries and correspondence in regulatory management system
  • Maintained and updated CCDS in RIM
  • Led project management and collaboration for timely annual product reviews
  • Collaborated with cross-functional teams (Asset team, SMEs, IT, quality) for drug development
  • Prepared APRs and records for compliance with regulatory guidelines
  • Completed data remediation projects ahead of schedule, boosting productivity by 20%
  • Created standardized report template, reducing report compilation time by 30%
  • Updated approved SOPs in myCIMS (EDMS) system
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Recommended improvements to processes.
  • Prioritized project-related tasks to efficiently complete essential tasks.

Bristol Myers Squibb

Senior Regulatory Affairs Specialist (CMC)
10.2021 - 03.2023

Job overview

  • Expertise in drafting, authoring, reviewing, and assessment of CMC dossiers (Module 2 and Module 3), Supplements, Annual Reports, and responses to Regulatory Authority questions to ensure Regulatory compliance is met
  • Reducing submission planning times by over 20% through stakeholder collaboration
  • Compile all documents from Mod 1, Mod 2, Mod 3, and Mod 5 based on submission need to be done
  • Collaborated with stakeholders and regulatory operations team in planning submissions for NDA, BLA, MAA, IND, NDS, sNDA, OD to Health Authority
  • Supported submissions/ publishing and content plan creation in Veeva RIM and DocuBridge
  • Demonstrated expertise in generating both commercial and development CMC change control events in quality system
  • Managed the planning and coordination of CMC related submissions with regulatory functions
  • Tracked approvals and provide regulatory input for changes implementation strategy in close collaboration with Quality, Supply and CMC functions
  • Acted as a CMC information creation and remediation project lead
  • Assisted in collaborative authoring and reviewing of regulatory fillings such as, Annual Report, stability report, Drug Master File (DMF) and Amendments
  • Managed the monthly remediation of DQ (Data Quality) issues in a timely and accurate manner, ensuring data integrity and compliance
  • Contributed to the review of CMC change control guidelines and regulations, offering valuable insights and recommendations to ensure compliance and optimize the change control process
  • Proactively ran weekly reports to check for any DQ issues, which help minimize the DQ issues by 40% at the end of the month
  • Managed workflows in regulatory management system Veeva RIM
  • Reduced submission review timelines by effectively managing cross-functional teams to ensure timely completion of tasks.
  • Wrote or updated standard operating procedures, work instructions or policies.

Eli Lilly

Global Clinical Regulatory Specialists
10.2020 - 10.2021

Job overview

  • Technical leadership of the Regulatory Affairs function to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan
  • Lead FDA pre-submission meetings for new INDs and NDA
  • Worked with records from the start of clinical trials through withdrawals of the marketed application
  • Coordinate with regulatory scientists on strategic submission planning
  • Expertise in electronic submission/publishing (generally 70 Global submissions per month) regulations and guidance and technical content for global submissions. This includes but us not limited to all submission types (Ad Promo, INDs, NDA, BLAs, NDSs, OD, sNDA, accelerated approvals other eCTD MAAs, Renewals and Variations), and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
  • Served as the regulatory operational lead for registration planning and execution including but not limited to: planning sessions (weekly) and status updates, team operation meetings and local department planning.
  • Trained 15 international new hires in the first 6 months of joining and mentoring
  • Plan initial IND submission by leading KOM and communicating with the team after KOM to do on time submission
  • Assisted in preparation and submission of applications for IND’s NDA, sNDA, BLA, MAA and NDS with US FDA and HC, EU standards and Regulatory Guidance Checklists
  • Helped in preparation of annual report, DSUR, PSUR, PADER and orphan drug DSUR
  • Helped in strategically planning US and OUS (health Canada, Australia, swiss and EU) submission
  • Expert knowledge in creating content plan and publishing in eCTDXPress, Veeva RIM
  • Knowledge in running validations using (Lorenz and Extido) for HC, Swiss, EMA and Australia
  • Created guidebooks for improvement of submission process
  • Participated in development of SOP
  • Project Management skills in pre sNDA and 4 Initial IND’s submission and planning

Education

Jawaharlal Nehru Technology University
India

Bachelor of Science from Pharmacy

Skills

  • Mentoring and Training
  • ECTD Global Submission Planning in Veeva Vault RIM
  • Project Management
  • SOPs
  • Strategic Planning
  • Post Approval Changes
  • Submission/publishing of Annual Reports DSUR, PSUR and PADER in eCTD express
  • CMC Regulatory Strategy
  • Knowledge of FDA Guidelines, ICH, GMP and GCP
  • CMC Change Control Management
  • Data Quality
  • Managing Workflows in Veeva Vault
  • Pharmaceutical Biotechnology
  • Technical Writing
  • IND Safety Reports
  • Internal Audits
  • Regulatory Information Management SME
  • RIM Super User
  • Regulatory submissions
  • Change control management
  • Project management
  • Data verification
  • Multitasking

Work Type

Full TimePart TimeContract Work

Work Location

RemoteOn-SiteHybrid

Timeline

Senior Global Regulatory Affairs Consultant

Moderna, Inc
10.2023 - Current

Regulatory Affairs Manager

BioGen
02.2023 - 05.2023

Senior Regulatory Affairs Specialist (CMC)

Bristol Myers Squibb
10.2021 - 03.2023

Global Clinical Regulatory Specialists

Eli Lilly
10.2020 - 10.2021

Jawaharlal Nehru Technology University

Bachelor of Science from Pharmacy

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Sabha Fatima