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Regulatory Affairs Executive

4 months ago

Vadodara Gujarat, India Ronak Group Full time

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