Regulatory Affairs Executive API

We are looking for candidates with 1 year plus experience in regulatory affairs for Active Pharma Ingredient Manufacturer company.

Regulatory Affairs (API) Preparation, review and submission of certificate of suitability applications for Active Pharmaceutical Ingredients for submission to European, USFDA and Rest – Of – World regulatory authorities.

1. Be the point of contact and support on regulatory matters.

2. Prepare draft for regulatory / DMF submission for API.

3. Generate, collect, compile & Review the regulatory submission documents. Compile and review Regulatory submission documents required in line with the relevant guidelines.

4. Ensure that company product comply with the regulation of the regions where they want to distribute them. Review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data

5. Keep up to date with national and international legislation, guidelines and customer practices.

Skills:

1 Excellent working proficiency in English.

2 Ability to plan, work in a dynamic and challenging environment.

3 Communication and collaboration skills.

4 Proficiency in MS office applications.

5 Data and information Management Skills.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹30,000.00 per month

Benefits:

• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Yearly bonus

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory affairs: 1 year (Preferred)

Work Location: In person