Director, Regulatory Lead, Development & Partnered Products
About Witty Health
Witty Health is a Houston, TX-based company (www.wittyhealth.com) focusing on commercializing intelligence-powered, real-time health drug toxicity monitoring based platforms, products and devices that improve outcomes, Quality of Life (QoL) and reduce preventable treatment costs of cancer. Witty Health is redefining the cancer treatments through the development and commercialization of its proprietary Cancer Treatment Platform (CTP™), Pain Treatment Platform (PTP™) and Hematologic Treatment Platform (HTP™) targeting $180 billion cancer and related therapeutic areas with high unmet needs.
We are in discussions with top biopharmaceutical companies for partnerships and have initiated the development of six products that provide more than $10.0 billion independent market opportunities.
Position: Director, Regulatory Lead, Development & Partnered Products
As a part of our Global Regulatory Affairs strategy, we are looking for a Regulatory Strategist for lead asset development program and partnered projects. This position will have the overall responsibility for the lead and partnered asset’s regulatory goals and ensure that these are met via close collaboration with partners and US and global regulatory agencies. This position will be responsible for providing regulatory strategies input to the US and global development plans. This individual will liaise with the FDA/EMEA on all development and marketed product related matters and act as a lead, agent, and moderator at FDA/EMEA meetings.
Roles and Responsibilities:
- This is a senior management position with significant upsides as normally associated with high technology industries.
- The designs of Witty Health’s platforms, products and devices are very unique. The Director, Regulatory Lead requires creativity and imagination as in many cases there are may not be any pre-established regulatory pathways.
- This individual will work with FDA, EMEA and other regulatory agencies to find or may even design a pathway and pilot our development and partnered projects to market.
- Collaborates closely with large pharmaceutical companies for proposed regulatory strategies/risks/mitigation plans
- We are a very nimble company in a fast changing technology space at include software, precision medicine, sensor and monitoring technologies. So we are looking for someone who is comfortable in a dynamic start up and development stage environment who can find regulatory solutions.
- BA/BS degree in one of the life sciences required; advanced degree with M.S., Pharm. D., Ph. D, etc, preferred.
- 10+ years of experience gained working in the Pharmaceutical/Biotechnology industry; Majority of this experience must be in the field of biologics and or development of small molecules or devices.
An Equal Opportunity Employer
Witty Health Inc.
5850, San Felipe, Suite 500
Houston. TX 77057
Phone: (713) 470-2580
Direct: (732) 939-3421