# Vaishali Tiwari

Vaishali Tiwari is a remote worker on Himalayas, Executive, Regional Regulatory Affairs at Sun Pharmaceuticals Industries, based in India.

Source: https://himalayas.app/@vaishalitiwari

```text
Regulatory Affairs Executive at Sun Pharma preparing EU and other regional submissions, variations, and health authority responses.
```

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | India |
| Authorized to work in | India |
| Salary expectations | 2277k+ INR |
| Job categories | Regulatory Affairs Specialist |
| Skills | Regulatory Affairs, Regulatory Compliance, Module 1 Submissions, Module 2 Compilation, Module 3 CMC Documentation, Pre Approval Variations, Postapproval Variations, Health Authority Query Management, Label Review, Artwork Review, National Phase Submissions, Dossier Compilation, ICH Q1A(R2) Stability Protocols, Manufacturing Records, Batch Packaging Records |

## What I'm looking for

```text
I’m looking to continue working in Regulatory Affairs, applying my experience with regional submissions, variations, labeling, and health authority responses.
```

## About

```text
At Sun Pharmaceuticals Industries, I prepare, compile, and review Module 1 and Module 3 submissions for pre- and post-approval variations across EU, Australia, New Zealand, and UK markets. My work also includes national phase submissions, labeling activity, and responses to health authority queries.

I coordinate technical data with relevant teams and communicate with regulatory agencies to clarify variation requirements. For labeling updates, I coordinate requests for new mock-ups and artwork through the AAM system and provide release confirmation to the plant.

Previously, at Mylan Laboratories Ltd. Pvt. (A Viatris Company), I coordinated Module 3 CMC documentation for new submissions and site transfers across multiple regions. I also prepared departmental SOPs in D2 Documentum and worked with SAP and Trackwise on project-related activities; at Sun Pharma, I received the Star Performer Award in 2025 and 2026.
```

## Experience

### Executive, Regional Regulatory Affairs (current)

[Sun Pharmaceuticals Industries](https://himalayas.app/companies/sun-pharmaceutical-industries-ltd). Apr 2024 - Present

```text
Currently working on Module 1 & 3 activities for Europe, AUS, NZ & UK markets, handling pre- and post-approval variation submissions, query responses, and national phase entries. Coordinated technical data and communicated with regulatory agencies to facilitate discussions on variations.
```

Skills: Module-1, Module-3, Pre-Approval-Variations, Postapproval-Variations, Query-Management, Labeling, Artwork-Review, Regulatory-Compliance, eCTD, Adobe-Acrobat-Professional, Microsoft-Office, AAM, Agile

### Executive, Regulatory Affairs

[Mylan Laboratories Ltd.](https://himalayas.app/companies/1100-mylan-pharmaceuticals-inc). Dec 2018 - Apr 2024

```text
Coordinated Module 3 CMC activities for new projects and site transfers across multiple regions, ensuring timely submission of responses to queries and post-approval variations for EU and US. Managed regulatory filing documents and coordinated with quality and cross-functional teams.
```

Skills: CMC-Documentation, Regulatory-Submissions, Postapproval-Variations, Query-Management, SAP, Trackwise, Documentum-D2, Project-Management, Cross-Functional-Collaboration, Microsoft-Office

## Education

### Dr. H.S. Gour Central University

Master of Pharmacy, Pharmaceutics. 2016 - 2018. Grade: 77.77%

Activities and societies: GPAT scholarship by AICTE (2016-2018)

```text
Pursued Master of Pharmacy with specialization in Pharmaceutics, achieving 77.77%.
```

### Dr. H.S. Gour Central University

Bachelor of Pharmacy, Pharmacy. 2012 - 2016. Grade: 7.86 CGPA

```text
Completed Bachelor of Pharmacy with a CGPA of 7.86.
```

### Saraswati Shishu Mandir Moti Nagar

12th Board, General. 2011 - 2012. Grade: 80.2%

```text
Completed 12th grade from M.P. Board with 80.2%.
```

### Saraswati Shishu Mandir Moti Nagar

10th Board, General. 2009 - 2010. Grade: 84.83%

```text
Completed 10th grade from M.P. Board with 84.83%.
```

## Tech stack

- Microsoft Excel
- SAP
- Adobe Acrobat Pro
- Microsoft Word
- Microsoft PowerPoint

To contact Vaishali, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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