Job Details

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.
Builds strong interface with NTO/ESO/QA functions. Interacts with those functions to optimize processes to achieve regulatory and business targets.
In cooperation with other regulatory functions, assesses and improves KPIs and metrics on second wave submissions/change evaluation/maintenance/variations/renewals.
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.
Ensures that oversight on maintenance (variations) is in place. Guides the regulatory organization to make sure that established processes and timelines for maintenance is followed.
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.

• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Ph.D.
• Excellent communication skills.
• Around 12 + Years Experience in Regulatory Life Cycle Management (If Sterile Oncology Injectable products experience then it is good)
• Around 5 years experience in people leadership
• Strong project management skills and negotiation skills
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player

Reference ID - GH/PHL/JC//30062020//91432/Group Head-Maintenance Regulatory Centers