Regulatory Affairs Executive

2 days ago

Mumbai Maharashtra, India TheTalentforte.com Full time

If you are interested in this opportunity, please send your updated CV + Current CTC

Manufacturer and 100% Exporter of Pharmaceutical Formulations

**REGULATORY AFFAIRS EXECUTIVE**

Job Location: Vikhroli West, Mumbai

Work Timings: 2nd & 4th Sat Off, Timings: 9.30 TO 6 OR 10 TO 6.30

Salary Range: 4 to 5 Lacs PA, depending on experience

B. Pharma / M. Pharma **OR** Science Graduate with Diploma in Reg. Affairs

4 to 5 years’ experience in Pharma Regulatory Affairs ROW market (Formulations)

**JOB PROFILE**

1. Preparation, Compilation of the CTD/ACTD dossiers for the ROW market (Formulations)

2. Compilation of dossier/Renewals/Variations /Query responses etc

3. Ensuring that quality standards are met and submissions meet within stipulated timelines.

4. Prepare accurate and timely responses to queries received from regulatory agencies.

5. Ensure that all product artwork is updated and submitted in correct format

6. Communicate and follow up with the agent for progress of registration submission.

7. Maintain record for the Dossier and sample submission.

8. Coordinate with other departments for for relevant documents required for dossier.

9. To review all the documents for accuracy as per ICH or Country specific requirement.

10. Responsible for Compilation & Review of Quality documents like RM/FP, STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.

11. Arranging samples, working standard, artwork as per country requirement and submitting them to the Regulatory authority within a specified time frame.

12. Maintaining & updating country wise registration status and arranging for renewal.

13. Should have experience in Pharma Formulation Company

**COMPETENCIES REQUIRED**
- Should possess good technical knowledge & review skills
- Should have an understanding of regulatory submissions
- Knowledge of CTD /ACTD requirements for submission of dossiers
- Good analytical and problem-solving skills.
- Ability to try new approaches when faced with challenges.
- Proactive & work independently with minimum supervision
- Excellent communication skills

*There is no virtual interview, only face to face interview.

Regards

Pooja Nair

Schedule:

- Day shift

Work Location: In person

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