Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

SAMUEL MUSI

Quincy,MA

Summary

Experienced Regulatory Affairs Specialist with a strong background in regulatory operations. Skilled in managing regulatory information systems, ensuring compliance, and optimizing processes. A detail-oriented professional with expertise in document management, submission planning, and quality control. Excels in cross-functional collaboration and project management.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Regulatory Information Management Consultant

Bristol Myers Squibb
05.2023 - Current
  • Responsible for the creation of investigational marketed product amendment events in Veeva Vault RIM
  • Conducted internal audits and HA inspections.
  • Performed corrective preventive action plans.
  • Initiated workflows for assessment of events with cross-functional colleagues.
  • Served as data steward for IMP CMC events in RIM
  • Assisted in uploading of dossiers in RIM database.
  • Created submission content plans.
  • Created and ran periodic Veeva Vault reports for status of clinical studies, health authority (HA) commitments, responses to HA questions, post marketing commitments.

Regulatory Affairs Specialist II

Sanofi-Aventis Pharmaceuticals
05.2021 - 05.2023
  • Preparation of Submission Content Plans for domestic and international CMC amendments.
  • Preparation of high quality submission documents for development and lifecycle management projects.
  • Collaborative review of supporting technical documentation For submissions and response to Health Authority questions and commitments.
  • End to End creation of events, applications, submissions, registration and regulatory objectives on Veeva Vault RIM for regulatory submissions
  • Veeva report generation for status updates for health authority questions and post approval commitments.
  • Change control assessment and regulatory strategy input for manufacturing site specific changes.
  • Tracking of IND/CTA amendment submissions to support clinical supplies.
  • Scheduling and planning of submissions with cross-functional Regulatory strategy teams.
  • Coordinated activities with external publishing teams.

Regulatory Scientist CMC

Voisin Consulting Life Sciences
03.2020 - 05.2021
  • Drafting, review and assembling of high quality (modules 3 and 2.3) sections for MAA, NDA, BLA, IND, IMPD regulatory submissions
  • Benchmarking and gap analyses for US to EU regulatory submissions for biological products and NCEs
  • Managing project workflows, including prioritizing project objectives, and establishing timeframes for projects with clients.
  • Lead cross-functional teleconferences with clients and vendors to discuss progress of drafting activities.

Pharmacist

NHS England
09.2009 - 03.2018
  • Worked with automated dispensing systems to securely store medication and track narcotics and other controlled drugs.
  • Conducted medical device training to treat and rehabilitate illnesses and diseases safely.
  • Maintained appropriate drug records and completed reports as necessary.
  • Educated patients about possible drug interactions and gave special administration instructions.
  • Communicated issues and reactions to specific medications to intercept potential errors.

Education

Master of Science - Regulatory Affairs: Drugs And Medical Devices

Northeastern University
Boston, MA
12.2019

Master of Science - Pharmaceutical Enterprise

University of Birmingham
Birmingham UK
12.2015

Master of Pharmacy - Pharmacy

University of Sunderland
Sunderland UK
06.2008

Skills

  • Mastery of Veeva Vault Regulatory Information Management Suite and Trackwise
  • Thorough understanding of change control management
  • Product Life Cycle Management
  • Excellent technical writing, analytical and computer skills
  • Impeccable communication skills, fluent in English and French
  • Expert Microsoft Word, Excel, PowerPoint, SharePoint, SmartSheet
  • Strong attention to detail and proven multi-tasking and organizational skills in fluid environments
  • Interpersonal skills working individually, and as part of cross-functional teams
  • Mastery of FDA regulations for drugs, biologic products, medical devices (IVD) Ability to interpret and analyze FDA guidance and 21 CFR regulations
  • Understanding of EUMDR and International Regulations and ISO 13485
  • Submission planning and tracking
  • Excellent Technical Writing

Certification

Project Team Leadership - University of Wisconsin October 2023

RAPS-Regulatory Affairs Certificate: Medical Devices 2024

Timeline

Regulatory Information Management Consultant

Bristol Myers Squibb
05.2023 - Current

Regulatory Affairs Specialist II

Sanofi-Aventis Pharmaceuticals
05.2021 - 05.2023

Regulatory Scientist CMC

Voisin Consulting Life Sciences
03.2020 - 05.2021

Pharmacist

NHS England
09.2009 - 03.2018

Master of Science - Regulatory Affairs: Drugs And Medical Devices

Northeastern University

Master of Science - Pharmaceutical Enterprise

University of Birmingham

Master of Pharmacy - Pharmacy

University of Sunderland
SAMUEL MUSI