Regulatory Operations Specialist - Publishing and Registration

Alcon Laboratories India Pvt Ltd; Bengaluru; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Alcon Laboratories India Pvt Ltd in Bengaluru hires for Regulatory Operation - Publishing & Registration. The role focuses on submission-ready formatting, template compliance, and compiling regional submission packs (US/EU/Canada) with bookmarks, hyperlinks, and cross-references for regulatory submission.

You will operate publishing tools such as Veeva RIM Publishing, draft POA and LOA, and prepare Free Sale Certificates.

Job description

Regulatory Operation - Publishing & Registration

• Apply submission-ready formatting & template compliance
• Compile packages per regional format (US/EU/Canada) and render PDFs with bookmarks, hyperlinks, cross-references for submission
• Operate publishing tools (Veeva RIM Publishing)
• Draft Power of Attorney (POA) and Letters of Authorization (LOA)
• Prepare Free Sale Certificates (FSC)
• Determine eligibility for and request CFG-NE
• Populate controlled templates with version control
• Cross-map documents across eSTAR / IMDRF ToC / MDR

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Experience Level Mid Level