![Hi Tech Biosciences India Pvt Ltd](https://media.trabajo.org/img/noimg.jpg)
Jr. Officer
3 weeks ago
**Position: Jr. Officer - RA**
Position category: Jr. team member
Unit / Department: Regulatory Affairs
Minimum Qualification: B.Pharm/M.Pharm
Total years of Experience: 1 -3 years. **Fresher do not apply.**
**Job Description & responsibility.**
1. Assist in preparation of submissions of license modification & renewal.
2. Assist in compilation of documents required for returns Site license renewal.
3. Data compilation for preparation of CTD, DMF/ Dossier or as per requirement of each country.
4. Organize and maintain regulatory documentation in a format consistent with current RA practice.
5. Keeping track of new regulations and follow up and updation of new regulation as per requirement.
6. Preparation of SmPC, Product insert.
7. Regulatory content writing and review for product artwork.
8. Customer communication regarding product registration, artwork approvals.
9. Help marketing preparing information leaflets as per applicable regulations.
10. Collecting, collating and evaluating scientific data regarding product registration.
11. Participate in driving compliance with the quality system within regulatory affairs in assigned area of responsibility.
12. Support to QA in non-routine activities related to regulatory work.
Industry type: Pharma/ food/ nutra
Reporting to: Manager
Post type: Permanent Gender Preference: Male/Female
Preferred Age group: 25-30 yrs
**Job Types**: Full-time, Permanent
**Salary**: ₹180,000.00 - ₹220,000.00 per year
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
Application Question(s):
- Do you have experience in the pharma industry?
- Are you Ready for Extended hours working ?
**Education**:
- Bachelor's (preferred)
Ability to Relocate:
- Pune, Maharashtra: Relocate before starting work (preferred)
**Speak with the employer**
+91 9225668416
Application Deadline: 22/11/2023
Expected Start Date: 20/11/2023
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