# Akshay User

Akshay User is a remote worker on Himalayas, Quality Control Intern at Relief Laboratories, based in India.

Source: https://himalayas.app/@akshayuser14

```text
Regulatory Affairs candidate pursuing an M.Pharm, with knowledge of CMC Module 3 and post-approval variations for global submissions.
```

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | India |
| Authorized to work in | India |
| Salary expectations | 70k+ INR |
| Job categories | Regulatory Affairs Associate |
| Skills | Regulatory Affairs, CMC Regulatory Affairs, CTD, eCTD, Module 3, Postapproval Variations, Change Control, Regulatory Change Assessments, Regulatory Submission Grouping, Global CMC Regulatory Requirements, US Regulatory Requirements, Regulatory Requirements, ROW Regulatory Requirements, ICH Q8, ICH Q9 (Quality Management) |

## What I'm looking for

```text
I'm seeking an entry-level Regulatory Affairs (CMC) role supporting global submissions and variations.
```

## About

```text
I'm pursuing an M.Pharm in Regulatory Affairs at Kishoritai Bhoyar College of Pharmacy, Kamptee, with academic knowledge of CTD structure, CMC Module 3, and regulatory requirements for US, EU, and ROW markets.

My studies cover post-approval changes, change-control evaluation, regulatory impact assessment, and submission grouping concepts. I'm familiar with ICH Q8/Q9/Q10, GMP principles, and QMS documentation.

As a Quality Control Intern at Relief Laboratories, Nagpur, I assisted with laboratory testing in accordance with GMP and SOP requirements. I also gained exposure to quality documentation, analytical records, and sample handling.

For an academic project, I formulated a herbal nutraceutical jelly with Shankhpushpi and almond extracts, developing and evaluating three trial batches. I reviewed literature on the ingredients and documented the formulation development and evaluation process.
```

## Experience

### Quality Control Intern

Relief Laboratories. Jun 2023 - Jun 2023

```text
Assisted in laboratory testing activities in accordance with GMP and SOP requirements. Gained exposure to quality documentation, analytical records, and sample handling procedures.
```

Skills: GMP, SOP流程设计, Quality-Control, Analytical-Records, Lab-Sample-Handling

## Education

### Kishoritai Bhoyar College of Pharmacy

M.Pharm, Regulatory Affairs. 2025 - Present

```text
Pursuing Master of Pharmacy in Regulatory Affairs, with expected completion in the future.
```

### Vidyabharati College of Pharmacy

Bachelor of Pharmacy, Pharmacy. 2021 - 2025. Grade: 7.37/10

```text
Completed Bachelor of Pharmacy with a CGPA of 7.37 out of 10.
```

### Tip Top Convent

Class XII, General Studies. Grade: 92.16%

```text
Completed Class XII with 92.16%.
```

### Maharishi Vidya Mandir

Class X, General Studies. Grade: 83.4%

```text
Completed Class X with 83.4%.
```

## Tech stack

- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint

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

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