Regulatory Affairs Consultant


JOB TITLE Regulatory Affairs Consultant – Sydney Based JOB SUMMARY A Regulatory Affairs Consultant is required for a small but growing life sciences organisation company. This company spans a wide portfolio including presciption and OTC. The company has recently experienced some exciting growth recently and is looking for a versatile candidate that would be able to support a number of indications and OTC product lines. ROLE/DESCRIPTION

  • Broad based Regulatory position
  • Regulatory Submission to ANZ
  • Prescription and OTC products
  • NCE applications
  • Submission and approval of Cat 1 / NMAs
  • Cat 3 variations
  • Marketing Authorisations
  • Mentor junior members of the team

REQUIREMENTS

  • Life sciences degree (pharmacy preferred)
  • Extensive experience in Australian Regulatory Affairs (and New Zealand ideally)
  • Experience with TGA and Medsafe
  • Reimbursement experience would be be preferred
  • OTC, Prescription and other product types would be preferred

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 [email protected] 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. 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.



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