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Senior Consultant - Regulatory, Quality & Compliance

Job description

Benefits:
  • Work from anywhere in Australia
  • Opportunity to mentor and develop junior staff
  • Exposure to diverse projects across pharma and biotech
 
About the company:
A leading consultancy firm specializing in regulatory affairs, quality, and compliance for the healthcare and life sciences industries.
 
About the opportunity:
Join our client's dynamic Regulatory, Quality & Compliance team as a Senior Consultant, managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region. This role offers the chance to work on diverse projects, from large global pharma to small biotech's.
 
Duties:
  • Manage multiple client projects simultaneously
  • Develop regulatory strategies and pathway options
  • Prepare and review regulatory submissions, including literature-based applications
  • Liaise with clients and regulatory authorities
  • Mentor junior team members
  • Contribute to business development initiatives
  • Provide expert advice on regulatory affairs and compliance
  • Assist in responding to regulatory agency questions
  • Support product lifecycle management activities
 
Skills and Experience:
  • Degree in Science/Pharmacy or related discipline
  • Minimum 8 years' experience in Australian/global regulatory affairs (Rx and biologicals preferred)
  • Strong knowledge of TGA/Medsafe regulations and guidelines
  • Experience in clinical data evaluation and presentation of clinical and non-clinical data
  • Confidence in handling challenges and finding solutions
  • Commercial acumen and understanding of the broader healthcare environment
 
Culture:
Our client fosters a supportive and friendly environment where people genuinely care about each other. Out client values work-life balance and offers a close-knit culture with hands-on support for new team members. Join them to be part of a high-performing team that celebrates collective success.
 
How to Apply:
Click apply or contact Erin Cox at ecox@hpgconnect.com or Jo Turner at jturner@hpgconnect.com for a confidential discussion.
 
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.
  • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
  • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
  • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
  • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.
 
For more job opportunities, visit www.hpgconnect.com.

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