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Job Id
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18126
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Title
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Regulatory Affairs Specialist
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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Job Description
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- Regulatory Affairs Specialist is responsible for facilitating and supporting various regulatory activitiessupporting multiple customers. The Regulatory Affairs Specialist reports to the Regulatory Affairs Manager.
- Responsibilities Include:
- Execute strategy and provide regulatory support and input. Deliver projects and other initiatives toprogress current product portfolio by providing regulatory direction and support to stakeholders.Demostrate strong project management skills by ensuring project deliverables and timelines are met.?
- Facilitates regulatory-based projects with assistance from Regulatory Affairs Manager?
- Assess impact of new regulations and guidances. Work with stakeholders to implementrequirements within specified timelines. Keep current with all relevant guidances and regulationswhile monitoring any changes that occur which may impact the current clients.?
- Previews and reviews change notices to assess regulatory status impact?
- Reviews documentation required to support various regulatory activities? Assists with regulatory approval application preparation and submission process? Reviews labeling and promotional materials to ensure compliance with FDA, European Union andother international requirements?
- Assists with FDA customs import/export requests, customer service needs, and other requestsfrom internal or external customers?
- Initiates and updates technical files/registrations as necessary for ANDA, DMF and 505(b)(2)?
- Collect and collate data required for registration submissions (eCTD, SPL, etc).?
- Prepare submission packages for the appropriate Regulatory Agency.?
- Correspond with the appropriate Federal or State Agency regarding registration submissions.?
- Performs other duties and responsibilities as the company may assign from time to time,including non-Regulatory Affairs assignments, as required
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Qualification
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Certification/Licensure
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Experience
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4-8 yrs
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Job Category
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Regulatory
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Posted On
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7/8/2018
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Expires On
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12/8/2018
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