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April

Regulatory Affairs Associate

Neo Health (OTC) - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

About us

Neo Health (OTC) Pty Ltd is a full-service pharmaceutical company developing and in-licensing over-the-counter medicines and medical devices as well as complementary, niche and innovative products for the Australia and New Zealand markets. We are suppliers to pharmaceutical multinationals and pharmacy chains in Australia and New Zealand. At Neo Health (OTC) Pty Ltd, we embrace a futuristic mindset to get you innovative products and services you can trust. Our chief competencies are registering medicines and medical devices with governing authorities, forecasting future demand, business analytics and offering compliant products registered with TGA or Medsafe.


Qualifications & experience

  • Relevant tertiary university qualifications.
  • Thorough knowledge, understanding and experience of relevant guidelines.
  • Preferably 3+ years of pharmaceutical experience in Regulatory Affairs.
  • Strong communication, analytical and systems skills.


Tasks & responsibilities

  • Prepare and compile registration applications, major & minor variations and responses to questions (S31) to ensure ongoing compliance in CTD, eCTD, (Module 1, Module 2 (QOS), and Module 3 (CMC)) with eCTD validation.
  • Review of existing registration dossiers for pharmaceutical products like OTC, prescription products and Active Pharmaceutical Ingredients (APIs, DMF, Applicant Part, CEP) to identify administrative and technical deficiencies that may influence the likely success or failure of the application.
  • Review Product Information (PI) and Consumer Medicine Information (CMI) documents for registered products.
  • Co-ordinate with sites (API and FDF) for GMP Clearance documents as per GMP clearance Pathway (MRA & CV) guidance TGA.
  • Transfer product technology from development trials to submission.
  • Utilise knowledge of artwork for submission and approval of artwork for final print as per TGO 91/92.
  • Check that all labelling, promotional materials and packaging materials meet Australian regulatory requirement.
  • Utilise analytical skills like technical review of Analytical Method Validation, Specification, test methods, Process validation, Comparative dissolution profile, Child Resistance study, Microbiological data as per TGA regulatory requirement.
  • Gap analysis of the current marketing authorization to identify any 'updating' required to comply with current regulations.
  • Manage in-house databases including Registration and SDS database for all products.


Benefits

  • Attractive salary + superannuation.
  • Ongoing opportunities for learning and development.
  • Opportunity to grow your career with a fast-growing company.

Sydney, NSW

Health, Medical & Pharmaceutical




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