Regulatory Affairs

4 days ago

Ahmedabad, Gujarat, India Medwise Overseas Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Roles and Responsibilities

  • Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities.
  • Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc.
  • Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format.
  • Preparation of query response for submitted applications received from various regulatory authorities.
  • Responsible for review of change controls and checking for regulatory compliance for all documents.
  • Exposure of Dossier compilation for ACTD & CTD is mandatory.
  • Coordination with the external stakeholders for the preparation of the regulatory documents.
  • To be responsible for the Life cycle management of assigned products.
  • Should have experience for Life cycle management and license Maintenance.
  • Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market.

Desired Candidate Profile

  • Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market.

Perks and Benefits

  • Best in industry.

Immediate Joiners preferred

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