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Shilpa Medicare

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based on 697 Reviews

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5 Shilpa Medicare Jobs

Regulatory Affairs (US - Formulations) - Executive/Sr Executive

Shilpa Medicare

·

based on 697 Reviews

5-10 years

Hyderabad / Secunderabad

1 vacancy

Regulatory Affairs (US - Formulations) - Executive/Sr Executive

Shilpa Medicare

posted 6mon ago

Job Role Insights

Fixed timing

Key skills for the job

PV Europe Regulatory Affairs RA Formulation MFC

+ 6 more

Job Description

Roles and Responsibilities

Should Have Formulation Experience.

US Regulatory Affairs. Submission of ANDAs.
Drafting/ Compilation/ Publishing of dossiers for US Submissions.
Response to information request/ Deficiencies from US FDA in timely manner.
Injectable Dosage Forms & Complex Generics
Post approval Supplements, Annual Reports.
To update cross functional teams for different regulatory compliance & requirements

Desired Candidate Profile

Perks and Benefits

Employment Type: Full Time, Permanent

Functional Areas: Other

Read full job description

Prepare for Regulatory Affairs roles with real interview advice

Top Shilpa Medicare Regulatory Affairs Interview Questions

Q1. During Compression Line Clearance, if the weight of the Blend is less than the Given Limit,as a IPQA what is ur Action

asked in Executive interview

View answers (2)

Q2. How do you convert reverphase to normal phase in hplc

asked in Quality Controller interview

View answer (1)

Q3. What is the time lines for CEP approvals

asked in Deputy Regulatory Affairs Manager interview

View answer (1)

View all 44 questions

What people at Shilpa Medicare are saying

Regulatory Affairs salary at Shilpa Medicare

reported by 1 employee with 1 years exp.

₹2.2 L/yr - ₹2.8 L/yr

62% less than the average Regulatory Affairs Salary in India

View more details

What Shilpa Medicare employees are saying about work life

based on 697 employees

58%

70%

55%

98%

Strict timing

Monday to Saturday

No travel

Day Shift

View more insights

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