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 - Maintenance Regulatory Centers (MRC)
The Group Head, MRC Leads and manages a team of regulatory affairs managers/team lead(s) responsible for regulatory second wave submissions and maintenance activities for Sandoz Small Molecules to achieve regulatory and business objectives.
- Acts as a competent and strong business partner on maintenance/compliance matters within regulatory affairs and for NTO/ESO/QA.
- Evaluates, manages and coordinates strategic projects.
- Builds strong interface with NTO/ESO/QA functions.
- Interacts with those functions to optimize processes to achieve regulatory and business targets.
- Ensures efficient working methods in accordance with the Guide to Good Regulatory Practice and internal guidelines as applicable.
- Leads, directs and motivates the team. Ensures proper training of the staff and development to maximize regulatory competence and strategic capabilities.
- Ensures that proper guidance and training for maintenance regulatory managers on regulatory requirements is in place.
- Develops and implements submission scenarios and plans to achieve overall regulatory and business objectives.
- Supports NTO/ESO/QA on evaluation as well as execution of strategic projects. Provides best in class regulatory input to NTO/ESO/QA for decisions making. Acts as competent and strong business partner for NTO/ESO/QA.
- Ensures that oversight on maintenance (variations) is in place. Guides the regulatory organization to make sure that established processes and timelines for maintenance are followed.
- Supports reporting KPIs and metrics for maintenance regulatory activities
• Scientific academic degree, preferably in natural science (Chemistry, Pharmacy, Biology or equivalent) Masters or Ph.D.
• Good written and spoken English. Local language is an advantage
• 5 years’ experience in leadership with overall 12+ experience in regulatory affairs
• Strong project management skills
• Strong negotiation skills
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
Experience : 5+ years
Qualification : B.Pharm, B.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th December, 2019
See All Other Jobs in our Database