The Director of Regulatory Affairs provides direct regulatory support for multiple diagnostic projects within in the Novartis Molecular Diagnostic unit.
Develops and implements regulatory strategy for both companion diagnostics and standalone diagnostics.
Lead program efforts relative to premarket submission, diagnostic partnering, FDA interface, regulatory policy and practice.
Facilitate integration of Dx regulatory strategy within the Drug/Diagnostic Co-development.
This is a self-directed objective driven position with oversight lead by the Global Head of Regulatory Affairs. Ensure early diagnostic regulatory input around PoC and during clinical development to Technical and Clinical Development Teams for all diagnostic tests. Implement the vision for regulatory affairs for molecular diagnostics and the action roadmap for activities with the regulatory bodies beyond the actual programs to ensure Novartis’ interests are reflected. Collaborate closely with drug regulatory affairs for all companion diagnostic programs. Provide input for BD&L and M&A activities with respect to the regulatory risks and benefits of potential deals. Provide training for key stakeholders internal and external of MDx (e.g. DRA in pharma). Represents the Diagnostic regulatory team internally and externally with objective advocacy of the projects pipeline potential as well as the overall regulatory perspective in diagnostic regulatory
Note: This position is for either an Associate Director or Sr. Associate Director. The level at which this position will be filled will be commensurate with the experience of the candidate to whom the job is offered.
An advanced degree in life sciences or a related legal field.
Greater than 10 years work related professional experience.
7 years experience in drug/diagnostic regulatory affairs.
Knowledge of drug development and regulation affairs requirements. Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics. Have a track record in successful data submission for FDA and EMEA approval.
Profound understanding of molecular technologies and the impact on outcomes and diagnostic results Leadership capabilities working across cultures, expertise and backgrounds.
Excellent negotiation skills with regulatory staff on various levels of hierarchy.
Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
Outstanding verbal and written communication skills.
Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.