Page 20 - Pharmacy careers guide

REGulAToRy AFFAIRS
Job positions:
• Regulatory affairs associate
• Senior regulatory affairs associate
• Project manager
• Regulatory affairs manager
Duties:
• Prepares and reviews new drug applications, labels, reports and submissions
• Prepares regulatory documentation such as regulatory submissions to the TGA
• Drafts product information (PI) and consumer information
• Collaborates with all other functions in the company; guides internal teams on research, testing, product development and quality assurance
• Identifies and assesses potential pharmaceutical safety hazards
Requirements:
• Bachelor of Science, Pharmacy or similar degree qualifications
• Higher education such as a Master degree is beneficial
• Experience working with the TGA
• Ability to evaluate technical and legal
information
• Ability to meet and expedite specific
timelines
ClINICAl RESEARCH
Job positions:
• Clinical research associate
• Senior clinical research associate • Clinical project manager
• Clinical research manager
Duties:
• Manages and reports on all clinical trials from Phase I through to Phase IV but mostly involved in Phase III trials
• Identifies and recruits clinical investigator/ sites
• Trains investigators and provides resources
• Oversees data collection and analysis
• Ensures Good Clinical Research Practice
(GCRP) guidelines are being followed
Requirements:
• Bachelor’s or higher degree in a health/science related field or a similar background in life sciences
• Good understanding of the drug development process
• Experience as a clinical trial administrator or clinical trial coordinator
• Courses undertaken at ARCS* are highly regarded
• Good report writing skills
For additional information on training courses please refer to Further study opportunities on page 40 of this Guide.
FuRTHER STuDy
• Master of Health Economics
• Master of Pharmaceutical Medicine
• Master of Public Health • PhD
*ARCS Australia Ltd (previously the Association of Regulatory and Clinical Scientists) is a professional development association for individuals working in the development of therapeutic goods. www.arcs.com.au
Pharmaceutical and Medical Professionals provide recruitment services to the pharmaceutical, medical, healthcare, scientific and biotechnology sector. www.pmpconnect.com
20 Pharmacy careers guide I ©Pharmaceutical Society of Australia Ltd.