Regulatory Affairs

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