Position: Regulatory Affairs Executive / Senior Executive (LATAM Region)
Industry: Vitane Pharmaceuticals Pvt. Ltd.
Location: Thane, Mumbai
Experience Required: 3–5 Years
Qualification: B. Pharm / M. Pharm
Key Responsibilities
· Preparation and submission of registration dossiers for LATAM countries.
· Handling site & product registrations, renewals, variations, and product lifecycle activities.
· Reviewing and compiling CTD/eCTD dossiers.
· Responding to queries and deficiency letters.
· Monitoring regulatory updates and ensuring compliance with country requirements.
Preferred Exposure
Experience in regulatory submissions for:
· Brazil
· Mexico
· Argentina
· Colombia
· Chile
· Peru
· Other Latin American countries
·
Desired Candidate Profile
- B.Pharm / M.Pharm qualification.
- 3–5 years of Regulatory Affairs experience in pharmaceutical exports.
· Hands-on regulatory experience in Latin American markets
- Knowledge of CTD/eCTD, ICH, WHO, and country-specific regulatory requirements.
- Strong documentation, communication, and coordination skills
Preferred skills:
- Experience using eCTD software such as EXTEDO
- Spanish/Portuguese language (advantage)
- Bottom of Form
Pay: ₹400,000.00 per year
Benefits:
- Flexible schedule
- Provident Fund
Work Location: In person
