Reference Number: JO-2002-445677
Vice President of Regulatory Affairs
Job Type: Permanent
Location: United States
An oncology biotech based in San Matteo California but with a significant international presence is looking for a VP of Regulatory Affairs.
The company is supported by investors that have the commitment to build a fully integrated R&D and commercial biopharmaceutical company to innovate, develop, and commercialize cutting edge cancer therapies.
They are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. The first clinical product is in Phase 3 pivotal clinical testing to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Given the rapid progression of the clinical studies they are quickly growing their teams to build and enhance in-house expertise with the intent to expand our R&D operations, clinical programs and prepare for the commercialization of products.
The Vice President of Global Regulatory Affairs will be a key leader of the management team and will provide management and leadership of the Regulatory Affairs to support the development and implementation of regulatory strategies and processes to secure worldwide product approvals.
The VP of Global Regulatory Affairs will work directly with functional leaders and external consultants and will lead the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.
Desired areas of expertise include the following: (i) clinical trial design including trial design for accelerated approvals, (ii) pharmacovigilance and drug safety compliance, (iii) regulatory submissions and discussions with the FDA, EMA and PMDA, (iv) CMC/cGMP of biologics to support pivotal studies and commercial launch, (v) device regulatory compliance for world-wide use, (vi) requests for orphan designation, breakthrough designation, fast track, accelerated approval, (vii) commercial launch and product promotional activities.
Understanding of Quality Assurance and Quality Management Systems will be valued.
They are looking for a hands-on candidate with strong leadership kills, a candidate that thrives in a fast-paced, highly interactive, and non-bureaucratic start-up environment, a candidate with excellent interpersonal skills that is determined to execute under tight timelines, a candidate that is energized by our mission to provide the patients with transformative treatments so they can conquer their disease.
This position can be remote anywhere in the USA.
For more information on this role and the company please CLICK APPLY and forward an up to date resume