Specialist - ROPS Publishing
Sandoz India Pvt Ltd
အလုပ်တည်နေရာ
Madhavaram, Telangana
အလုပ်ခန့်သည့်ပုံစံ
အချိန်ပြည့်
အလုပ်ခေါ်စာအသေးစိတ်
Job Description
Key Responsibilities:
• Support regulatory teams during the submission process in all administrative and technical steps according to global procedures
• Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements
• Ensure eCTD lifecycle maintenance according to ICH and regional specifications. Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant
• Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates
• Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents. Ensure escalation procedures are followed in case of issues and delays.
• Might be involved in document preparation activities like scanning bookmarking, linking and other activities to ensue document submission readiness. Might be involved in document bulk upload activities.
Essential Requirements
• Relevant 5+ years of experience in Regulatory Affairs
• Experience in the Regulatory submission publishing, area is preferred. Knowledge of Regulatory guidelines for the areas mentioned above.
• Organizational awareness and experience working cross-functionally and in global teams is a plus.
• All assigned project deliverables meet targets for quality, productivity in compliance with Regulatory and /or health authorities requirements
• Ability to work under pressure, demonstrating initiative and flexibility
• High level understanding of Regulatory quality, standards and policies.
• Attention to detail and quality focused and Team-minded
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
