Regulatory Affairs Executive
Job Description
Responsible to prepare and review of dossier as per CTD / ACTD / Country specific guidelines
Responsible for dossier compilation and query response
Co-ordination with Cross-Functional Team and Business Partners
To prepare and review all technical documents (SPEC, BMR, MFR, Validation reports etc)
Proficiency in literature search for products at various stage of R&D.
Ability to conduct secondary research and acquire information from internet sources, journals, public databases, etc.
Experienced and good hand-on drafting Clinical & non-clinical overview/summary.
Required knowledge of toxicity studies, BA-BE studies and clinical trials.
Working on regulatory agencies regarding
Pre-submission strategies, potential regulatory pathways.
Review of documents to ensure there are no gaps
Maintains the highest level of submission standards.
Maintains familiarity with evolving and/or new regulatory e-submission requirements maintains the highest level of submission standards.
Maintains familiarity with evolving and/or new regulatory e-submission requirements
Familiarization with evolving guidance of Row markets
Job Type: Full-time
Schedule:
• Day shift
Education:
• Master's (Preferred)
Experience:
• total work: 1 year (Preferred)
Work Location: In person
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Job Detail
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Job IdJD3385608
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IndustryNot mentioned
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Total Positions1
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Job Type:Contract
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationGJ, IN, India
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EducationNot mentioned
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ExperienceYear