Executive, Global Regulatory Affairs

চাকরির বিবরণ

SQUARE Pharmaceuticals PLC is recruiting an Executive for Global Regulatory Affairs at its Kaliakoir, Gazipur site. The role prepares CTD/ACTD dossiers for export markets, answers queries raised by regulatory authorities during dossier evaluation or facility inspection, and coordinates with departments on artwork and materials for new products. Only short-listed candidates will be called, hard copies of CVs are not accepted, and SQUARE never asks for money from any candidate at any phase of recruitment.

দায়িত্ব

• Prepare CTD/ACTD and dossiers for export markets
• Provide updated regulatory information to respective concerns and follow up the implementation
• Review and prepare technical documents associated with CTD/ACTD preparation
• Respond to queries raised by regulatory authorities during dossier evaluation or facility inspection
• Prepare annexure/recipes and arrange Drug Testing Laboratory (DTL) samples as required
• Check newly developed artwork with annexure for both local and export markets
• Maintain liaison with different departments and give feedback on inclusion materials for new products

যোগ্যতা

• M.Pharm / B.Pharm from a reputed university
• 1-2 years of relevant experience is preferable (especially Global Regulatory Affairs or Formulations R&D) but fresh graduates are encouraged to apply
• Excellent planning and execution skills with strong quantitative and qualitative analytical skills
• Readiness to perform in a shift-based operation
• Within 32 years of age

দক্ষতা

• Artwork Review
• CTD / ACTD Dossiers
• Pharmaceutical Documentation
• Regulatory Affairs