We currently have 1 position available:
Senior Director Regulatory Affairs & Quality Manager
The Senior Regulatory Director provides strategic and operational regulatory expertise for Vivet's programs, including, with respect to product development stage, valuation, strategic development plan with experts in the company, registration, and approval/post approval.
The Senior Regulatory Director defines and executes regulatory plans in line with the defined regulatory strategy. This is a strong leadership role responsible for ensuring compliance with regulations, while optimising interactions with regulatory authorities. The Senior Regulatory Director must understand and challenge the dynamic regulatory landscape, while creating opportunities in the highly-regulated and complex environment, specifically for ATMPs & orphan diseases.
As the Quality Manager, and with the support of a consulting group, ensure the implementation and follow up of a quality system regarding clinical, CMC (outsourced), regulatory and non-clinical activities, in line with a phase 1/2 clinical-stage company.
Please send your resume at firstname.lastname@example.org