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5 Shilpa Medicare Jobs

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

5-10 years

Hyderabad / Secunderabad

1 vacancy

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

Shilpa Medicare

posted 6mon ago

Job Role Insights

Fixed timing

Job Description

Roles and Responsibilities

Should Have Formulation Experience.

  1. US Regulatory Affairs. Submission of ANDAs.
  2. Drafting/ Compilation/ Publishing of dossiers for US Submissions.
  3. Response to information request/ Deficiencies from US FDA in timely manner.
  4. Injectable Dosage Forms & Complex Generics
  5. Post approval Supplements, Annual Reports.
  6. 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
Q2. How do you convert reverphase to normal phase in hplc
Q3. What is the time lines for CEP approvals
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 699 employees
58%
70%
55%
98%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Shilpa Medicare Benefits

Job Training
Health Insurance
Soft Skill Training
Free Transport
Cafeteria
Free Food +6 more
View more benefits

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