Embark on a rewarding journey in pharmaceutical regulatory affairs with Teva Pharmaceuticals Ltd! We’re thrilled to announce exciting opportunities for talented B. Pharma/M. Pharma graduates to join us as Regulatory Affairs Associate II. Be part of our dynamic team in Hyderabad and play a pivotal role in shaping the future of healthcare compliance. Seize this chance to propel your career forward with a global leader committed to making a difference in the pharmaceutical industry.
| Position | Regulatory Affairs Associate II |
| Department | Regulatory Affairs |
| Qualification | Degree in science/life science/pharmacy or equivalent qualification(s) |
| Experience | 1. Five to Six year experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered. 2. Desirable to have experience with preparation and compilation of Annual reports. 3. Handling of change controls and process. 4. Experience and through knowledge in assessing and filing of US post approval supplements. |
| Knowledge | 1. Desirable to have knowledge of US regulatory applications. 2. Understanding of processes and departments within a pharmaceutical company. |
| Salary | Competitive |
Job Description
As A Regulatory Affairs Associate II At Teva Pharmaceuticals, You’ll Play A Vital Role In Ensuring Compliance And Regulatory Submissions For Our Products. Your Responsibilities Will Include Compiling And Reviewing Annual Reports, Assessing Change Controls, And Coordinating Post-Approval Supplements In The US Market.
Key Responsibilities:
1. 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).
2. Assessing, reviewing and approving the change controls initiate by manufacturing sites.
3. Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US.
4. Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule.
5. Retaining all supporting documentation as required in completing an Annual Report.
6. Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.
Skills:
1. Excellent Oral And Written Communication Skills.
2. Ability To Work Under Pressure And Meet Tight Deadlines.
3. Effective Time And Organization Management.
4. Negotiation Skills.
5. Analytical Skills (Data And Documentation).
6. Computer Literacy.
7. Teamwork And Collaboration.
8. Attention To Detail.
9. Planning And Organization.
| Date | Apr 10, 2024 |
| Location | Navi Mumbai, India, 400059 |
| Company | Teva Pharmaceuticals |
| Job Id | 55243 |
| Apply Online | Click Here |
