Regulatory Affairs Executive

Roles & Responsibilities
• Compile and submit regulatory dossiers in CTD, ACTD, eCTD, and country-specific formats
• Prepare and respond to regulatory queries, deficiency letters, and notices of deficiency
• Coordinate with QC, QA, Production, and other departments for regulatory documentation
• Handle license renewals, variations, updates, and re-registrations
• Maintain regulatory databases, trackers, and product chronologies
• Compile technical dossiers for tender submissions
• Review BMRs, stability protocols and reports, specifications, and validation documents
• Initiate and review artworks, labels, SmPC, package inserts, cartons, and foils
• Ensure compliance with ICH guidelines and country-specific regulatory requirements
• Support the RA Head and assist in team reporting and regulatory activities

Qualification
• B.Pharm or M.Pharm

Experience
• 2–10 years of hands-on experience in Regulatory Affairs
• Proven exposure to ROW and EU dossier submissions
• Mandatory experience with parenteral formulations

No. of Openings: 10

Skills
• Strong knowledge of CTD, ACTD, and eCTD submissions
• Excellent understanding of ICH guidelines
• Expertise in deficiency response preparation
• Good documentation, coordination, and communication skills
• Ability to manage multiple regulatory projects and timelines

About the Organization
Swiss Parenterals Ltd. is a leading Indian pharmaceutical manufacturing company specializing in sterile and parenteral formulations, with a strong presence in global regulated and semi-regulated markets, offering stable growth and long-term career opportunities in regulatory affairs.