Regulatory Affairs Executive Pharma Jobs in Noida

Pharma company in Noida is hiring Regulatory Affairs Executives to prepare dossiers, file registrations and track approvals for domestic and export markets.

The role includes coordinating with R&D, QA, QC and manufacturing teams to ensure products and documents meet current regulatory requirements.

• Dossier Preparation

  Prepare CTD / ACTD dossiers, product permission applications and other regulatory documents as per country guidelines.

• Filing & Registration

  Submit applications to regulatory authorities, track query responses and maintain updated status of approvals.

• Regulation Monitoring

  Monitor changes in pharma regulations and pharmacopeial updates and communicate impact to internal teams.

• Label & Artwork Review

  Review product labels, cartons and promotional materials to ensure compliance with regulatory and legal requirements.

• Documentation & Audit Support

  Maintain regulatory files, registration dossiers and support audits and inspections with required documentation.

• Education

  BPharm / MPharm / MSc in Life Sciences with interest and exposure in regulatory affairs.

• Experience

  1-4 years experience as Regulatory Affairs Executive / Officer in pharmaceutical company.

• Technical Skills

  Basic understanding of CTD / ACTD formats, regulatory guidelines and documentation for product registration.

• Other Requirements

  Good communication, coordination skills and attention to detail in documents and submissions.