Associate - ROPS Publishing
Sandoz India Pvt Ltd
Lokasi pekerjaan
Madhavaram, Telangana
Status Pekerjaan
Waktu penuh
Detail Pekerjaan
Job Description
Your Key Responsibilities:
• Support preparation and dispatch/submission of documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements
• Support regulatory teams during the submission process in all administrative and technical steps according to global procedures
• Support timely update of submission data in the regulatory information management databases and verify that the data is kept compliant
• Ensure escalation procedures are followed in case of issues and delays
• Support planning, tracking and reporting activities as requested
Essential Requirements
What you’ll bring to the role:
• On-time filing dispatch/submission, quality within IM&S responsibilities, customer satisfaction (e.g. regulatory competence, responsiveness)
• All assigned deliverables are completed in time, and meet targets for quality and compliance with Regulatory and /or health authorities’ requirements Adherence to Sandoz policy guidelines -Project & stakeholder feedback.
Desirable Requirements
• Knowledge of Regulatory guidelines is a plus
• Attention to detail and quality focused also team oriented and embracing diversity of cultures and personalities
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape
