Regulatory Affairs Associate

Work Type

Location

Closes

Full Time

NSW

30/04/2021

Job description

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.