Regulatory Affairs Executive
4 months ago
Looking for an Enthusiastic, Efficient & Trustworthy Senior Executive - Regulatory Affairs for a Leading MNC “**Ronak Group”**
**Company: Ronak Group (MNC)**
Position**:Executive / Senior Executive - Regulatory Affairs**
Experience: 2 to 7 Years
Location: Vadodara, India
We are looking for Energetic & Goal Oriented **Executive / Senior Executive - Regulatory Affairs** Person who can:
**Job Summary**:
- Documentation work for procuring Product Permission, CoPP.
- To co-ordinate with QA-QC and other departments to get technical documents for dossier preparation & compilation.
- To review the technical documents for dossier submission.
- Dossier Preparation for all dosage forms**:ACTD, CTD and Country specific dossier within a time line.**:
- Reviewing of the Dossiers prepared by team members before dispatching to the country.
- Timely submission of Dossiers / Query reply / variation submission to various export markets.
- Preparation of error free documents in best possible time.
- Monitoring own work progress and to ensure that documents are submitted to customer for registration within deadline
- Response to NOD (Notice of Deficiencies): Preparation of responses for National queries from all various authorities as well as customer queries.
- Maintain the Status & backup records for the dossiers/queries and other related documents that has been sent to Regulatory authorities/International marketing Dept. /Customers
- **Artworks checking & confirmations.**:
- Brand name search and trade mark registration
**Regards,**
Karan Shah
Talent Acquisition Executive
Ronak Group
Mob no: +91 9173767010
**Job Types**: Full-time, Permanent
Pay: ₹20,000.00 - ₹40,000.00 per month
**Benefits**:
- Food provided
- Health insurance
- Leave encashment
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
- Yearly bonus
Work Location: In person
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