Job Description
Teva, a global pharmaceutical leader and the world’s largest producer of generic medicines, is seeking a Regulatory Affairs Associate II to join our team. With a commitment to improving health and increasing access to quality healthcare solutions worldwide, Teva offers an exciting opportunity for individuals passionate about making a difference.
Key Details
- Position: Regulatory Affairs Associate II
- Location: Navi Mumbai
- Industry Type: Pharma/ Healthcare/ Clinical research
- Functional Area: Regulatory Affairs
- End Date: April 30, 2024
Responsibilities
- Compile and review Annual Reports, ensuring timely submission
- Assess, review, and approve change controls initiated by manufacturing sites
- Compile and submit post-approval supplements (CBE 0, CBE 30, PAS) in the US
- Coordinate retrieval of supporting documentation for Annual Reports
- Retain all required supporting documentation for Annual Reports
- Notify the Regulatory Affairs Manager of any risk of late Annual Report submission
Candidate Profile
- Degree in science/life science/pharmacy or equivalent qualification(s)
- 5-6 years of experience in the Pharmaceutical Industry, preferably in Regulatory Affairs, R&D, Development, or QA
- Experience with the preparation and compilation of Annual Reports is desirable
- Experience in handling change controls and processes
- Thorough knowledge of assessing and filing US post-approval supplements
- Knowledge of US regulatory applications is desirable
- Understanding of pharmaceutical company processes and departments
Skills
- Excellent oral and written communication
- Ability to work under pressure and meet tight deadlines
- Effective time and organization management
- Negotiation skills
- Initiative and analytical mindset
- Computer literacy
- Teamwork and collaboration
- Attention to detail
- Planning and organization
Don’t miss this opportunity to join Teva and contribute to our mission of improving health globally. Apply now and be part of our dedicated team!