Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sharina Beliveau

Goffstown,NH

Summary

I am a dedicated Senior Regulatory Affairs Associate that's been given the opportunity to specialize in regulatory strategy development and documentation accuracy. My current experience has allowed me to excel at problem-solving, communication, and teamwork to navigate complex regulatory environments successfully.

Overview

3
3
years of professional experience

Work History

Senior Regulatory Affairs Associate

Keros Therapeutics Inc.
Lexington, MA
06.2022 - Current
  • Prepared submissions, such as INDs, CTAs, and amendments, in accordance with applicable regulations.
  • Provided guidance to internal departments on the impact of changes to core regulatory documents or manufacturing processes to maintain regulatory compliance.
  • Developed and implemented strategies to ensure compliance with global regulatory requirements.
  • Created and maintained a comprehensive filing of regulatory documents for TMF.
  • Interacted with health authorities globally in order to obtain approval of CTAs.
  • Reviewed product labeling, advertising material, promotional literature and other marketing materials for accuracy and compliance with local regulations.

Regulatory Affairs Intern

Alkermes
Waltham, MA
02.2022 - 05.2022
  • Participated in cross-functional meetings to develop strategies for obtaining CTA approval in the United States and various non-United State regulatory agencies
  • Collaborated with internal departments such as Research and Development, Clinical Operations and Regulatory Compliance and Marketing Communications teams on various projects relevant to regulatory affairs.
  • Conducted research on global product registration requirements.

Education

Doctor of Pharmacy - Pharmacy

Massachusetts College of Pharmacy & Health Science
Manchester, NH
05-2022

Skills

  • Regulatory Submissions (global)
  • FDA regulations, ICH, 21 CFR, GMP, EMA
  • EU CTR CTIS Management
  • Regulatory Strategy for CTAs
  • Orphan Drug Designation
  • Fast Track Designation
  • Change Controls
  • Training and mentoring
  • Mono eCTD viewer
  • Study Maintenance

Timeline

Senior Regulatory Affairs Associate

Keros Therapeutics Inc.
06.2022 - Current

Regulatory Affairs Intern

Alkermes
02.2022 - 05.2022

Doctor of Pharmacy - Pharmacy

Massachusetts College of Pharmacy & Health Science

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Sharina Beliveau