US-NJ, Manager Reguatory Affairs Process Implementation 226319BR-MZ
Manager Reguatory Affairs Process Implementation
Global Drug Development
REG AFFAIRS GDD
East Hanover, NJ
Research & Development
Responsible for the development and implementation of enhanced quality processes and procedures to manage mandatory trainings for RA GDD worldwide. Support non-mandatory training initiatives and appropriate communication strategy for RA as assigned.
1. Be a permanent member of the RA Process Review Committee (PRC) to assess SOPs training applicability, review SOPs content/ for RA input. 2. Manage assignment of SOPs, WPs and FRMs to relevant roles in RA, and maintain train-ing curricula information, including all assigned RA and cross functional procedural doc-uments (new and updated). 3. Support change management activities related to the implementation of new processes or organizational changes in the function through adequate metrics and appropriate train-ing and communication plans. 4. Prepare the RA GDD organization for internal global audits related to SOPs and training 5. Help to devise and implement relevant remedial and improvement actions for Corrective Action Plans from training audits and follow-up on completion and implementation of rel-evant tasks to ensure closure. 6. Collaborate with QA to prepare RA for external inspections at HQ relevant to SOPs and training. 7. Manage deviations/incidents related to trainings in the appropriate system together with RA GDD groups according to timelines. 8. Support and/or participate in cross-functional process improvement projects to represent the function. 9. Work with Director RA Process Implementation to address potential quality issues and emerging compliance concerns and recommend solutions.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Life Science Degree or other University degree with equivalent experience English Eight years Pharmaceutical working experience with at least three in Regulatory Affairs Basic knowledge of global regulatory requirements Ability to work in a matrix cross functional environment Strong analytic, influencing, and communication skills.
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