Sr. Executive Regulatory Affairs
Year Gandhinagar, Gujarat, India
Job Description
Job Title: Sr. Executive - Regulatory AffairsJob Location: Gandhinagar, Gujarat, IndiaJob Location Type: On-siteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelSkills:
Knowledge of regulatory requirements, Attention to detail, Strong communication skills, Project management, Ability to work under pressure, Research skills, FDA,We are hiring for Sr. Executive - Regulatory Affairs.Qualification: B.pharm/M.pharmExperience - 2 to 5 years onlyLocation - Sola, AhmedabadWork mode - on siteRole & responsibilities:-
- Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
- Technical documents like Raw Material and finished products specification, manufacturing process,
- Product development report, stability reports, process validations preparation & review.
- Analytical method validation review as per the ICH guideline.
- Drug Master File review
- Technical query response to the various regulatory authorities.
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Job Detail
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Job IdJD3589596
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationGandhinagar, Gujarat, India
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EducationNot mentioned
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ExperienceYear