Regulatory Affairs Officer

Role overview

This position supports corporate regulatory affairs with documentation and coordination needed for product submissions across multiple countries. The role focuses on keeping regulatory files complete, accurate, and aligned with compliance expectations.

Key responsibilities

• Assist the corporate regulatory affairs team in preparing materials required for regulatory filings in different markets.
• Pass on any regulatory gaps or deficiencies to the relevant departments and help route the supporting replies and documents back to Corporate RA for action.
• Support compliance by arranging the documents needed for DMF amendments, supplements/variations, and yearly updates within required timelines.
• Examine and sign off on applicable quality system records, master documents, and executed documents.
• Approve documents after aligning with the Site or Corporate Regulatory Affairs manager.
• Help create a structured method to track regulatory documents and information submitted against commitments, and contribute to departmental improvement initiatives.
• Assess post-approval changes to understand regulatory impact and support related submissions.
• When needed, discuss filing strategy with Corporate RA and coordinate with other teams to clarify submission requirements.

Experience and education

The position calls for 1 to 2 years of relevant experience and a graduation degree in Pharmacy.

Competencies

• Customer focus
• Talent development mindset
• Cross-functional collaboration
• Strategic thinking
• Process improvement orientation
• Stakeholder coordination
• Innovation and problem solving
• Results-driven approach

Additional information

Location: Dhar, Madhya Pradesh, India. Employment type: full-time, on-site.