NIBR Global Regulatory Submission Manager

263883BR
NIBR Global Regulatory Submission Manager
150 plus global submissions ranging from INDs/CTAs to NDAs for you to be involved in your role as Submissions Manager as part of the Clinical Sciences & Innovation team within NIBR's Translational Medicine group.

The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. Within TM, Clinical Sciences and Innovation (CS&I) is a dynamic group of clinical scientists who plan and manage all NIBR’s Phase I and Phase IIa clinical trials worldwide, ensuring they run smoothly, on time and – most importantly – with patients’ interests to the fore.

In the Global Regulatory Submission Manager role your responsibilities will include but are not limited to:

• Lead the global NIBR submission team and manage NIBR deliverables for submissions such as INDs, IMPDs and CTA, Health authority responses and annual reports.
• Develop and track timelines for NIBR components of submissions by partnering with NIBR authors and contributors
• Serve as the subject matter expert for the above submission activities and provide guidance to line functions.
• Support senior team members on NDAs and MAAs.

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.
What you bring to the role:

• BA/BS degree in a scientific discipline or business administration or equivalent experience
• Fluent in English (oral and written)
• Intermediate project management experience with demonstrated ability to work within a matrix environment, influence cross-functional teams and maintain a customer focused mindset.
• Self-starter with a proven ability to work diligently against timelines and pressure, to think independently and take a flexible and detailed approach
• Basic knowledge of external regulatory environment related to drug development and document management systems
NIBR
Translational Medicine
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular