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155 Sun Pharmaceutical Industries Jobs

Sr.Officer - India Regulatory Affairs

0-5 years

Vadodara

1 vacancy

Sr.Officer - India Regulatory Affairs

Sun Pharmaceutical Industries

posted 14hr ago

Job Description

Job Title:

Executive

Job Grade:

G12A

Department:

India Regulatory Affairs

Sub-function:

Corporate Relations

Location:

Tandalja

Job Summary

Regulatory submissions of drugs and medical devices in India.

Area Of Responsibility

  • Evaluation of regulatory strategies for products to be registered in India.
  • Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI.
  • Evaluation and submission of applications on online portal for import registration/import license of drugs and medical devices in India.
  • Evaluation of the documents that need to be submitted with the applications and coordinating with the respective team for finalization.
  • Evaluation and submission of application for getting BE permission for export registration.
  • Evaluation and submission of application for getting permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13.
  • Evaluation and submission of application for getting permission to import drugs for examination, test or analysis in Form-11/Form CT-17.
  • Evaluation and submission of application for getting permission to import drugs in Form 8.
  • Evaluation and submission of applications for getting permission to import medical devices for examination test and analysis in MD-16.
  • Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same.
  • Evaluation and submission of response to the market complaints raised by regulatory authority.

Work Conditions:

Physical Requirements:

Travel Estimate

Only if required

Education and Job Qualification

M. Pharm

Experience

0-5 years experience required in Regulatory Affairs for India Market.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).


Employment Type: Full Time, Permanent

Read full job description

Prepare for Regulatory Affairs roles with real interview advice

Top Sun Pharmaceutical Industries Regulatory Affairs Interview Questions

Q1. How will you start RS method Development for known drug product?
Q2. What is peak purity and how it is calculated in hplc?
Q3. 1 - Which biological indicator use in autoclave validation at the time of RVSEB media cycle i.e. 115 C ?
View all 224 questions

What people at Sun Pharmaceutical Industries are saying

Regulatory Affairs salary at Sun Pharmaceutical Industries

reported by 2 employees with 1-6 years exp.
₹2.5 L/yr - ₹3.2 L/yr
56% less than the average Regulatory Affairs Salary in India
View more details

What Sun Pharmaceutical Industries employees are saying about work life

based on 5.8k employees
51%
65%
42%
97%
Flexible timing
Monday to Saturday
No travel
Day Shift
View more insights

Sun Pharmaceutical Industries Benefits

Submitted by Company
Health Insurance
Job Training
Free Transport
Soft Skill Training
Submitted by Employees
Health Insurance
Job Training
Free Transport
Soft Skill Training
Cafeteria
Child care +6 more
View more benefits

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