Regulatory Affairs Associate
Year Bengaluru, Karnataka, India
Job Description
Regulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
- To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
- Liaise closely with cross-functional members with aligned product responsibilities.
- Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Authoring the dossier sections based on the changes to approved MAA
- Knowledge of change evaluation according to country guidelines
- Experience in managing lifecycle activities in the EU markets would be preferrable
- Knowledge of CTD guidelines
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Job Detail
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Job IdJD3202195
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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 LocationBengaluru, Karnataka, India
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EducationNot mentioned
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ExperienceYear