Regulatory Officer

2 weeks ago

Sydney, New South Wales, Australia Pharma - Contract Manufacturer Full time $60,000 - $120,000 per year

A rapidly growing pharmaceutical manufacturing company, based in Smithfield, has vacancy for a competent, dedicated and experienced Regulatory Officer

Duties and responsibilities include:

  • Dossier preparation in accordance with overseas authorities requirements

  • Responding to queries from TGA and other health authorities

  • Review and approval of packaging materials and other artwork

  • Preparation of the registration documentation in timely manner

  • Preparation of marketing authorisation in timely manner

  • Assistance in documentation system

  • Preparation of formulation certificates

  • Collecting technical and general documentation

  • Drafting Product Listings and Applying for Certificate of Pharmaceutical Product through TGA EBS system.

  • Legalisation of documents

  • Training junior regulatory officers

Requirements and skills:

  • Tertiary qualification in science / B Pharm

  • Previous experience with regulatory departments

  • Experience in compiling CTD dossier

  • Attention to detail

  • Excellent written, computing and verbal communication

  • Team player

If you believe you are qualified for this role, please send your resume.

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