Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager - Development Regulatory Centers
1. All assigned projects have clearly defined regulatory strategies in order to optimize the development work and time to market
2. Regulatory filings/dossiers are prepared and/or reviewed as per established development milestones
3. Timely regulatory approval is obtained by relevant Health Authorities.
• Elaborates global regulatory strategies for new product development.
• 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.
• 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 DRC and SDC personnel.
• Provide regulatory training and coaching to the DRC associates, as needed.
• 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 SDC team members. Provide support for health authority inspections.
• Science degree (Pharmacy, Chemistry, Biochemistry). English, other languages are an asset.
• Relevant work experience: 5 to 8 years - Minimum 5 years Regulatory Affairs experience or similar pharmaceutical regulated environment.
• Original submission experience with oral dosage forms is required.
• Excellent communication skills. High level of organizational skills. Positive attitude, problem solving mindset.
• Extensive hands-on knowledge with CTD Module 2, 3 and 5.
• Good knowledge of business process and project management in development of generics.
• Solid knowledge of ICH, EMA, US FDA, ROW guidelines and regulatory procedures.
Experience : 5-8 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 10th January, 2020
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