Position: Regulatory Affairs Executive / Senior Executive (CIS)
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 CIS market.
· 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:
- Russia
- Kazakhstan
- Uzbekistan
- Belarus
- Azerbaijan
- Other Eurasian/CIS markets preferred
Desired Candidate Profile
- B.Pharm / M.Pharm qualification.
- 3–5 years of Regulatory Affairs experience in pharmaceutical exports.
· Knowledge of EAEU regulatory framework (Eurasian Economic Union)
- 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
· Russian language (advantage)
Pay: ₹400,000.00 per year
Benefits:
- Cell phone reimbursement
- Provident Fund
Work Location: In person
