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!
The post Join Teva: Regulatory Affairs Associate II Opportunity Available first appeared on Pharmacy Freak.
