Job Description

Dear Candidate,

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

Candidate Criteria

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

Job Type: Full-time

Schedule:

• Day shift

Work Location: In person