Senior Executive
Year Vadodara, Gujarat, India
Job Description
Job Title: Senior Executive
Job Grade: G11B
Department: Corporate Affairs
Sub-function: India Regulatory Affairs
Location: Tandalja(Baroda)
Job Summary: * To make applications to India regulatory authority for getting clinical trial (CT)/bioequivalence (BE) study/manufacturing-marketing permission of new drugs after review of various documents like CMC documents/CT-BE documents etc.
- To compile dossier for filing the applications to Regulatory Authority.
- To do literature search, to prepare rationale on safety and efficacy of new drugs.
- To review draft specimen of label/carton.
- To prepare prescribing information.
- To review for any update in Pharmacopoeia and accordingly to check impact on our products in case of any update.
- To support Global Pharmacovigilance by providing necessary information like permissions/prescribing information etc
1. To handle artwork activity wherein to track if any artwork is coming new for review, to allot within the team, to do secondary review of artworks and to track overall that it gets reviewed within given timeline.
2. To do overall activities for making applications to India regulatory Authorities.
3. To keep the track of any update in any Pharmacopoeia
Education and Job Qualification:
M-Pharm in any field
Experience:
5-10 years
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Job Detail
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Job IdJD3229882
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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 LocationVadodara, Gujarat, India
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EducationNot mentioned
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ExperienceYear