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 : Group Head, Development Regulatory
Job Description
Manage and develop staff and workflow/processes within DRC, ensures that the team has the knowledge and resources to perform as effectively as possible while adhering to and enforcing corporate standards. File new submissions to Regulatory Competence Center’s (RCC) within the agreed timeline, in compliance with global requirements and of acceptable quality. Support in budget preparation/monitoring/compliance. Performance appraisal; implementation and follow-up of development plans for assigned team. Coaching and training of the DRC staff with respect to global regulatory requirements and key competencies. Regulatory Competence Center (RCC) / DRC Interactions: Manage the day-to-day interactions with the RCC’s, developing and maintaining good relations, and thorough diligent follow-up and negotiations, ensuring that regulatory approvals are obtained as early as is possible and deficiency letters are answered in a timely matter. Review registration packages, health authority question responses and regulatory strategic decisions in order to receive marketing authorization as per established timelines. Regulatory Guidance: to provide accurate and timely regulatory guidance to internal, and where required-external stakeholders. To participate, where required, in the development and influence of regulatory policy. Participate in SDC management meetings where required, global meetings and communication forums. Report any changes or issues of interest to the management, transfer of information. Prepare presentations for communication forums. Adheres to all applicable company procedures and policies (Finance, Health & Safety, HR, Information Technology, etc.) and any other regulatory requirements related to the Pharmaceutical Industry (GMP, etc.). Promotes a company culture centered on Health & Safety to all employees and encourages them to maintain a safe and secure work environment at all times
Manage and develop staff and workflow/processes within DRC, ensures that the team has the knowledge and resources to perform as effectively as possible while adhering to and enforcing corporate standards. File new submissions to Regulatory Competence Center’s (RCC) within the agreed timeline, in compliance with global requirements and of acceptable quality. Support in budget preparation/monitoring/compliance. Performance appraisal; implementation and follow-up of development plans for assigned team. Coaching and training of the DRC staff with respect to global regulatory requirements and key competencies. Regulatory Competence Center (RCC) / DRC Interactions: Manage the day-to-day interactions with the RCC’s, developing and maintaining good relations, and thorough diligent follow-up and negotiations, ensuring that regulatory approvals are obtained as early as is possible and deficiency letters are answered in a timely matter. Review registration packages, health authority question responses and regulatory strategic decisions in order to receive marketing authorization as per established timelines. Regulatory Guidance: to provide accurate and timely regulatory guidance to internal, and where required-external stakeholders. To participate, where required, in the development and influence of regulatory policy. Participate in SDC management meetings where required, global meetings and communication forums. Report any changes or issues of interest to the management, transfer of information. Prepare presentations for communication forums. Adheres to all applicable company procedures and policies (Finance, Health & Safety, HR, Information Technology, etc.) and any other regulatory requirements related to the Pharmaceutical Industry (GMP, etc.). Promotes a company culture centered on Health & Safety to all employees and encourages them to maintain a safe and secure work environment at all times
Candidate Profile
Science degree (Pharmacy, Chemistry, Biochemistry). English, other languages are an asset relevant work experience: 8 years. Minimum 5 years managerial experience or equivalent. Minimum 5 years Regulatory Affairs experience or similar pharmaceutical regulated environment. Leadership skills with ability to manage team under pressure. Excellent communication skills. High level of organizational skills. Positive attitude, problem solving mindset. Extensive hands-on knowledge with CTD Module 3. Good knowledge of business process and project management in development of generics. Solid knowledge of ICH, EMA, US FDA guidelines and regulatory procedures.
Science degree (Pharmacy, Chemistry, Biochemistry). English, other languages are an asset relevant work experience: 8 years. Minimum 5 years managerial experience or equivalent. Minimum 5 years Regulatory Affairs experience or similar pharmaceutical regulated environment. Leadership skills with ability to manage team under pressure. Excellent communication skills. High level of organizational skills. Positive attitude, problem solving mindset. Extensive hands-on knowledge with CTD Module 3. Good knowledge of business process and project management in development of generics. Solid knowledge of ICH, EMA, US FDA guidelines and regulatory procedures.
Additional Information
Experience : 5-8 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : Development Regulatory
End Date : 5th December, 2018
Experience : 5-8 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : Development Regulatory
End Date : 5th December, 2018
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