Senior Manager DRC
Sandoz India Pvt Ltd
အလုပ်တည်နေရာ
Madhavaram, Telangana
အလုပ်ခန့်သည့်ပုံစံ
အချိန်ပြည့်
အလုပ်ခေါ်စာအသေးစိတ်
Job Description
Your Key Responsibilities:
• Elaborates global regulatory strategies for new product development and Ensures that all strategies are scientifically sound and in accordance with relevant regulatory requirements.
• Participate in project/product-related discussions and provides in-depth strategic, scientific and RA input, for CMC or procedural aspects of given project.
• Ensure planning and proper organization of activities in line with the overall project plan and project milestones. Ensure no delays in submission approval timelines or "first to file" opportunity losses due to gaps in the regulatory strategy and plans.
• Responsible for preparation and review regulatory submissions (e.g., ANDS, ANDA, SNDS, NDA) and responses to Health Authority queries.
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements and Continuously improves the quality of dossiers sent to the regulatory authorities ensuring optimal review timelines.
• Training and regulatory oversight. Search, analyze, interpret and implement international regulations, guidelines and policies as they pertain to Sandoz products. Transfer new regulatory related information by preparing internal workshops for training of both RA team and CFTs.
• Provide regulatory training and coaching to the RA team, as needed and Participate in the development and implementation of standard operating procedures. Act as the point of contact for Global Regulatory Affairs initiatives/programs.
• Provides support and coordinates with relevant team members. Provide support for health authority inspections. Support to new joiners in on-boarding process. Review of generic applications to ensure regulatory compliance.
Essential Requirements
• Relevant experience: 10 - 15 years in Regulatory Affairs
• Knowledge of ICH, US FDA, EMA guidelines and regulatory procedures.
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and work load.
• Adherence to Sandoz policy and guidelines -Project & stakeholder feedback
Desirable Requirements
• Effective planning, organizational and interpersonal skills.
• Good written/spoken communication and negotiation skills
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
