Regulatory Affairs Officer

1 week ago

Mumbai, India TheTalentforte.com Full time

**REGULATORY AFFAIRS EXECUTIVE**

Job Location: VIkhroli Mumbai

Qualification: B.Pharma / M.Pharma OR MSc + Diploma in Drug Regulatory Affairs

Experience: 3 to 4 years in Regulatory Affairs of Pharma Formulations

**JOB PROFILE**

1. Preparation and submission of registration dossier in CTD/ACTD /country specific format for countries in CIS, Africa, South east Asia, Latin America and Middle east region.

2. Coordinate with Plant, R&D & CQA & ADL department for technical documents and to review the documents for accuracy as per ICH or Country specific requirement.

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

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

5. Liaise with marketing for the finalizing the product pipelines and providing required dossiers for submissions.

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

7. Checking & approval of artworks as per countries requirement.

8. 8. Arranging samples, working standard, artwork as per country requirement and submit them to Regulatory authority within specified time frame.

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

10. Maintain record for the Dossier and sample submission.

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

**COMPETENCIES REQUIRED**
- Good technical knowledge, review skills and understanding of regulatory submissions
- Knowledge of CTD /eCTD requirements for submission of dossiers
- Good analytical and problem-solving skills.
- Ability to try new approaches when faced with challenges.
- Should have a good analytical and learning attitude.
- Proactive to submission of response to any queries.
- Excellent communication skills

**If you find this opportunity interesting, please send us the following**:

- Your updated CV
- Current or last CTC:

- Your Residence location:

- Joining Period if you are selected

Regards,

Pooja Nair

TheTalentorte.Com

Pharmaceuticals & Chemicals Recruiter

Schedule:

- Day shift

**Speak with the employer**
+91 8097337489

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