Work as Regulatory Affairs Associate at Teva

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.

Your experience and qualifications

Qualification:

Degree in science/life science/pharmacy or equivalent qualification(s)

Experience:

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.

Knowledge:

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