Regulatory Affairs Executive (2-3 Years)

Key Responsibilities

Dossier Compilation & Submissions

Compile, review, and assemble high-quality regulatory dossiers (CTD, eCTD, ACTD, and local country formats) for product registrations in domestic and international target markets.

Prepare Module 1 (Administrative), Module 2 (Summaries), and Module 3 (Quality/CMC) documentation in close coordination with R&D, ADL, QA, and Production teams.

Prepare and submit variations, renewals, and post-approval changes in accordance with market-specific guidelines.

Regulatory Compliance & Labeling

Review artwork, packaging material, package inserts (PI), Patient Information Leaflets (PIL), and Summary of Product Characteristics (SmPC) to ensure compliance with country-specific labeling regulations.

Review change control proposals, master formula cards (MFC), manufacturing records, and stability reports to assess regulatory impact prior to implementation.

Track evolving global and domestic regulatory guidelines (CDSCO, FSSAI, USFDA, EMA, WHO) and inform internal stakeholders regarding compliance impacts.

Query Management & Inter-Departmental Coordination

Coordinate with cross-functional teams (QA, QC, ADL, Production, and Supply Chain) to gather technical data and documents required for regulatory filings.

Address and compile timely, comprehensive responses to queries raised by regulatory authorities and client regulatory representatives.

Maintain complete archival systems for raw data, submission packages, approval licenses, registration certificates, and health authority correspondence.

License Maintenance & Regulatory Approvals

Manage applications for manufacturing licenses, product permission endorsements, import/export permits, NOCs, and free sale certificates (FSC).

Maintain a centralized tracking system for license expiry dates, renewal deadlines, and regulatory milestones.

• Experience

  2 - 3 Years

• No. of Openings

  1

• Education

  Post Graduate (M.Pharma)

• Role

  Regulatory Affairs Executive

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face Interview Location

  Impact HR and KM Solutions Near Canada Corner Signal Ravi Chambers Basements Below Laminate Gallery, Nashik