Work as Group Head in Maintenance Regulatory Centers at Novartis

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)

Job Description
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

Candidate Profile
• 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

Additional Information
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