Principle / Manager Regulatory Affairs - Pharmaceuticals

JOB TITLE

Senior / Principal Regulatory Affairs Associate - Prescription - Sydney Based

JOB SUMMARY

A Senior / Principal Regulatory Affairs Associate is required for an exciting growing consultancy building their global operation from Sydney.

The company has recently had a large capital injection globally providing an exciting phase in their growth.

ROLE/DESCRIPTION

• Broad based Regulatory role
• Regulatory Submission to ANZ
• regulatory strategy
• cat 1 cat 3 applications
• Document Control
• Configuration Management

REQUIREMENTS

• Life sciences degree (pharmacy preferred)
• Extensive experience in Australian Regulatory Affairs (and New Zealand ideally)
• Experience with TGA and Medsafe
• Electronics or diagnostics background would be preferred
• Reimbursement experience
• People management would be a bonus
• Electronic QMS in a medical device setting
• visa / eligiblity to work in Australia

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.com. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

Quality Engineer, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 13485.

Principal Consultant, Senior RA Associate, Senior Regulatory Affairs Associate, Regulatory Affairs Associate, Regulatory Affairs Manager, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, Regulatory Training, Regulatory Trainer, Renewals.