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Regulatory Affairs Associate II
Teva Pharmaceuticals
Full time
5+ years
Not Disclosed
Mumbai, India
Post Date: Apr 12, 2024
End Date: Jun 12, 2024
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5+ years
Not Disclosed
Mumbai, India
Post Date:Apr 12, 2024
End Date: Jun 12, 2024
Skills:
pharma
Quality control
Regulatory Affairs
Job Description:
Roles and Responsiblities
Compiling and reviewing of the Annual Report and ensuring it is submitted prior to the commitment date (at minimum no later than the due date).
Assessing, reviewing and approving the change controls initiate by manufacturing sites.
Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US.
Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule.
Retaining all supporting documentation as required in completing an Annual Report.
Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.
Qualification and Experience
Degree in science/life science/pharmacy or equivalent qualification(s)
Five to Six year experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
Desirable to have experience with preparation and compilation of Annual reports.
Handling of change controls and process.
Experience and through knowledge in assessing and filing of US post approval supplements.
Job Overview
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Salary
Not Disclosed
Role
Associate
Area of Practice
Regulatory Affairs
Experience
5+ years
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