Vice President/Head, Regulatory Affairs
Diffusion Pharmaceuticals Inc. is an innovative publicly traded biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to the areas where it is needed most. Founded in 2001, the company’s mission is to enhance the standard-of-care treatment for conditions associated with hypoxia, a potentially fatal shortage of oxygen in tissue and a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Their lead product candidate, Trans sodium crocetinate (TSC), is a first-in-class, small molecule therapeutic with a novel mechanism-of-action that enhances the diffusion of oxygen to hypoxic tissues. The company’s second pipeline asset, DFN-529, is a novel, allosteric PI3K/Akt/mTOR pathway inhibitor. Two Phase I clinical trials have been completed evaluating DFN-529 in age-related macular degeneration and preclinical studies have been performed in preclinical models of glioblastoma multiforme (GBM).
The Vice President/Head, Regulatory Affairs
will develop and implement effective regulatory and related strategies for the development of Diffusion assets. The individual will put together overarching strategy while considering U.S. regulatory requirements, and provide regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders.
- Provides regulatory expertise and guidance within a collaborative cross-functional team.
- Acts as the direct liaison between Diffusion and the FDA.
- Advises and oversees the development and implementation of regulatory strategy through non-clinical, clinical, and other processes.
- Supports the preparation of, and participates in (as appropriate), key Health Authority interactions.
- Assures consistent positions on common issues are presented to Health Authorities.
- Drives the development and on time completion of Health Authority background documents and responses to queries from Health Authorities.
- Provides regulatory expertise to support Clinical Study teams.
- Provides strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs.
- Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs) and orphan drug designations.
- Sustains excellent relationships with regulatory agency personnel.
- Responds to requests for additional data, organizes and manages participation in meetings.
- Negotiates directly with regulatory authorities regarding company’s filings.
- Works cross-functionally to develop and implement revised/new strategies.
- Maintains regulatory strategy documentation for assigned projects.
- Requires a Bachelor’s degree or equivalent with an advanced degree preferred.
- Must have experience with IND submissions and Orphan Drug designations.
- Requires significant experience in Regulatory Affairs.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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