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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 3mon ago
Job Role Insights
Fixed timing
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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
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