Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Post : Regulatory Affairs Associate II
Job Description
• 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.
Candidate Profile
• 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.
• Desirable to have knowledge of US regulatory applications.
• Understanding of processes and departments within a pharmaceutical company.
Skills
• Excellent oral and written communication
• Ability to work under pressure and to tight time deadlines.
• Effective time and organization management
• Negotiation
• Initiative
• Analytical (Data and Documentation)
• Computer literacy
• Teamwork and collaboration
• Attention to detail.
• Planning and Organization
Additional Information
Experience : Five to Six year experience
Qualification : Degree in science / life science / pharmacy
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th April 2024
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