Senior Regulatory Affairs Executive

Talish Solutions; Ahmedabad District; On-site; INR 500,000 - 900,000; Full time

Job summary

Talish Solutions in Ahmedabad, India is seeking a Regulatory Affairs specialist to prepare and review CTD/eCTD dossiers for global registrations. You will manage registrations, renewals, and variations while handling regulatory queries and audits.

You will coordinate with R&D/QA/QC/Production to ensure global compliance, review labeling, and maintain up-to-date regulatory documentation.

Qualifications

• Prepare and review CTD/eCTD dossiers for regulatory submissions.
• Manage registrations, renewals, and variations with authorities.
• Handle regulatory queries and support audits.
• Coordinate with R&D/QA/QC/Production to ensure compliance and labeling.

Responsibilities

• Prepare/Review CTD/eCTD dossiers for global registrations.
• Manage registrations, renewals & variations; handle regulatory queries.
• Support audits and coordinate with R&D/QA/QC/Production for compliance.
• Review labeling and maintain regulatory documentation.

Skills

CTD/eCTD preparation

Regulatory submissions

Regulatory queries handling

Audit support

Cross-functional coordination

Global compliance

Labeling review

Regulatory documentation

Education

B.Pharma (Any Specialization)

B.Sc (Any Specialization)

M.Pharma (Any Specialization)

Job description

Prepare/review CTD/eCTD dossiers; manage registrations, renewals & variations; handle regulatory queries; support audits; coordinate with R&D/QA/QC/Production; ensure global compliance; review labeling; maintain regulatory documentation.

Role Category: Healthcare & Life Sciences - Other

Education

UG: B.Pharma in Any Specialization, B.Sc in Any Specialization

PG: M.Pharma in Any Specialization

Key Skills

Skills highlighted with ‘‘ are preferred keyskills

Third Party and Contract Manufacturing company of Pharmaceuticals, Nutraceuticals, Herbals Products.