A Senior / Lead Regulatory Affairs Associate is required for an interesting and unique cannabis medicines company. There will be a broad range of duties associated with driving and executing regulatory activities in ANZ.

This role will be with a view to export products overseas This will be supporting an onsite manufacturing company.

The company has experienced exciting growth and need a strong manager in this role who thrives on change, there may be possible line management duties further down the track.

 

JOB TITLE

Senior / Lead Regulatory Affairs Associate – 9 Months Contract

 

LOCATION

Melbourne – Australia

 

BENEFITS

Competitive Salary Package

 

ROLE/DESCRIPTION

  • Broad based Senior role supporting the global regulatory function.
  • Project Regulatory at this stage rather than line management responsibilities
  • Development of Regulatory Strategies with the Head of Compliance for ANZ
  • Involved in variation and new product registrations support with marketing
  • Maintenance of up to date Regulatory market knowledge
  • Liaise with external stakeholders
  • Some cross functional input needed across different functional areas within the business
  • line management responsibilities

REQUIREMENTS

  • Life sciences degree (pharmacy preferred)
  • Extensive experience in Australian Regulatory Affairs
  • cannabis or GMP manufacturing
  • ideally experience supporting global registrations
  • Quality Systems experience including ISO 9001: 2015 (pre-requisite)
  • Ability to multitask across different Regulatory Affairs disciplines efficiently

 

 

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 Practice Lead, 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

Regulatory Director, Regulatory Affairs Manager, Regulatory Consultant, Senior Regulatory Affairs 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.

Quality Systems Manager, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 9001:2015

Tom Desborough on (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.com