Summary
Overview
Work History
Education
Skills
Training
References
Area Of Expertise
Personal Information
Languages
Certification
Competencies
Timeline
Generic
Masrahayu Mustafa

Masrahayu Mustafa

Seremban

Summary

Persistent, organized, and detail-oriented individual interested in pursuing a position in the Pharmaceutical or Biotechnology field that would enable an organization to capitalize on experience and expertise acquired from previous job position as a Quality Assurance and Regulatory Affairs Executive.

Overview

12
12
years of professional experience
1
1
Certification

Work History

QUALITY & REGULATORY AFFAIRS EXECUTIVE

MYVAX Sdn Bhd
Seremban
05.2022 - Current
  • Key person for all submissions pertaining to product registration, license application to NPRA and MDA.
  • Key person for all communication with manufacturer/business partner for pharmaceutical products.
  • Key person for regulatory audits, inspection, compliance, and strategies including NPRA, CAB and JKNNS.
  • Acted as QA officer in development of QMS for the incoming GMP certification.
  • Acted as liaison between upper management and regulatory authority.

REGULATORY AFFAIRS EXECUTIVE

Southern Crescent Sdn Bhd
12.2020 - 04.2022
  • Key person for all tasks pertaining to product registration to NPRA and MDA.
  • Key person for all regulatory compliance, including strategies for inspection, submission, and licensing affairs.

Sr REGULATORY AFFAIRS EXECUTIVE cum CLINICAL RESEARCH COORDINATOR

Inno Biologics Sdn Bhd
11.2014 - 01.2020
  • Key person for pre and post registration product of Biologics/Biosimilar, Medical Device, NCEs etc
  • Manage regulatory authority applications and approvals, such as MREC, NPRA and MDA that oversees the research requirements and registration of new products and variation of existing/registered products
  • Keep updated on the changes and new regulatory requirements pertaining to clinical research conduct especially for registration of NCE, Biologics, Generics, Biosimilar, Medical devices etc
  • Prepare initial review and gap analysis report of Common Technical Dossier (CTD) for various types of pharmaceutical products (focusing on Clinical & Non-Clinical data)
  • Prepare and outline the scope of clinical development of a particular product, under discussion with Medical Professionals or Consultant as well as Product Development Partner or Product Owner
  • Evaluate proposal from Clinical Research Organizations (CROs), including management of appropriate agreements and documents
  • Involvement and coordination with appointed CRO during all stages of clinical trial, including identifying investigational sites and setting up, initiating, monitoring, data collection and closing of the trial
  • Communicate and liaise with parties related to clinical research, including CROs, Medical Professionals, Investigators, Site personnel and regulatory authorities
  • Summarize reports and progress of specific clinical research and updating to Management on the progress as well as any specific issues

Clinical Trial Coordinator

UiTM Selayang & Selayang Hospital (Centre for Translational Research & Epidemiology, CenTRE)
02.2013 - 11.2014
  • Served as a key point person for various clinical trials related to cardiovascular, cerebrovascular, and respiratory diseases.
  • Designed source document templates for each clinical research study, thereby optimizing the amount of correct data captured at each patient visit.
  • Effectively met deadlines and consistently exceeded expectations for timely data collection and submission.
  • Maintained accurate records of Adverse Events and expedited reports of Serious Adverse Events.

Education

Bachelor of Science (Hons) - Biology, minor in Management

Universiti Teknologi MARA, UiTM Malaysia
01.2012

Foundation of Life Science -

Pusat Asasi Sains Universiti Malaya (PASUM), UM Kuala Lumpur
01.2009

Pure Science -

MARA Junior Science College (MRSM) Serting
Negeri Sembilan
01.2007

Skills

  • Good Clinical Practice (GCP)
  • Good Distribution Practice for Medical Device (GDPMD)
  • Pre & Post product registration
  • NPRA & MDA submission
  • Biologics/ Biosimilar & Medical Devices
  • QUEST 3 system
  • Medc@ast
  • EUCTD & Asean CTD
  • Ethics in Clinical Research
  • Cardiology & Respiratory Trials
  • Documentation & Reporting
  • Electronic Data Capture (EDC)
  • Electronic Case Report Form (eCRF)
  • International Air and Transportation Association regulations (IATA)
  • Problem solving
  • Regulatory practices
  • Clinical practices

Training

  • MOPI Basic GMP Course 2024
  • MOPI Regulatory Plus Conference 2024
  • MOPI Good Distribution Practice 2023
  • National Regulatory Conference (NRC) 2023
  • Outreach Programme on Draft Code of Conduct for Biosecurity within the international Framework of the Biological and Toxin Weapons Convention 2016
  • CGTP and Biotherapeutics Seminar 2015

References

  • Mohamad Faez Fakharie Abd Halim, COO, Myvax Sdn Bhd, Nilai, Negeri Sembilan, 013-3811817
  • Norazrina Pakiman, Ex-VP of Regulatory Affairs, Inno Biologics Sdn Bhd, Nilai, Negeri Sembilan, 012-281 1477

Area Of Expertise

  • Good Clinical Practice (GCP) & Good Distribution Practice for Medical Device (GDPMD)
  • Regulatory Requirements for Registration & Variation: NPRA & MDA
  • Registration of Biologics & Medical Devices, QUEST 3+ system, Medc@ast
  • Common Technical Dossier (EUCTD & Asean CTD)
  • Ethics in Clinical Research
  • Cardiological & Oncological Clinical Trials
  • Reporting, Documentation & Purchasing
  • Biologics & Biosimilar Products
  • Electronic Data Capture (EDC) & Electronic Case Report Form (eCRF)
  • International Air and Transportation Association regulations (IATA)

Personal Information

  • Expected Salary: RM 3800 (negotiable)

Languages

Malay
First Language
English
Upper Intermediate (B2)
B2

Certification

  • Good Clinical Practice (GCP)

Competencies

  • Excels both independently and collaboratively
  • High adaptability in new situation, new task, and challenges
  • Knowledgeable and experienced in regulatory and clinical practices related to trial of pharmaceutical products
  • Strong capability in problem solving especially related to product registration

Timeline

QUALITY & REGULATORY AFFAIRS EXECUTIVE

MYVAX Sdn Bhd
05.2022 - Current

REGULATORY AFFAIRS EXECUTIVE

Southern Crescent Sdn Bhd
12.2020 - 04.2022

Sr REGULATORY AFFAIRS EXECUTIVE cum CLINICAL RESEARCH COORDINATOR

Inno Biologics Sdn Bhd
11.2014 - 01.2020

Clinical Trial Coordinator

UiTM Selayang & Selayang Hospital (Centre for Translational Research & Epidemiology, CenTRE)
02.2013 - 11.2014

Bachelor of Science (Hons) - Biology, minor in Management

Universiti Teknologi MARA, UiTM Malaysia

Foundation of Life Science -

Pusat Asasi Sains Universiti Malaya (PASUM), UM Kuala Lumpur

Pure Science -

MARA Junior Science College (MRSM) Serting

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Masrahayu Mustafa