Job Description
1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
The role of DRC Manager, Development Regulatory Center (DRC) is to ensure: Regulatory filings/dossiers are prepared and support DRC Manager as per established development milestones. Take project ownership within DRC for projects with lower degree of complexity and supports DRC Manager for high complex projects. Timely regulatory approval is obtained by relevant Health Authorities.
Your Responsibilities:
Your responsibilities include but not are limited to:
• 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.Other tasks as assigned by the supervisor, and tasks based on a specific appointment
• Other tasks determined during the annual objectives setting process and by KPIs
• Implementation of and compliance with all the instructions and requirements for safety at work, environment protection, and property protection
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
The role of DRC Manager, Development Regulatory Center (DRC) is to ensure: Regulatory filings/dossiers are prepared and support DRC Manager as per established development milestones. Take project ownership within DRC for projects with lower degree of complexity and supports DRC Manager for high complex projects. Timely regulatory approval is obtained by relevant Health Authorities.
Your Responsibilities:
Your responsibilities include but not are limited to:
• 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.Other tasks as assigned by the supervisor, and tasks based on a specific appointment
• Other tasks determined during the annual objectives setting process and by KPIs
• Implementation of and compliance with all the instructions and requirements for safety at work, environment protection, and property protection
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
• Regulatory experience mandatory (minimum of 5 years), and/or experience in pharmaceutical industry in US, EU, Most of world market etc.
• Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development of process desirable. Ability to critically evaluate data from a broad range of science disciplines.
• Solid knowledge of ICH, EMA, US FDA 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 workload.
• Effective planning, organizational and interpersonal skills.
• Excellent written/spoken communication and negotiation skills.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development of process desirable. Ability to critically evaluate data from a broad range of science disciplines.
• Solid knowledge of ICH, EMA, US FDA 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 workload.
• Effective planning, organizational and interpersonal skills.
• Excellent written/spoken communication and negotiation skills.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
