Director Regulatory Affairs
Company: Urovant Sciences
Position: Director Regulatory Affairs
Location: Irvine, CA
Posted: April 30, 2021
Improving quality-of-life through innovations in urology.
Urovant Sciences, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and improving the way providers and their patients confront urologic diseases that are difficult to treat.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA® is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH).
Urovant’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.
The Director of Regulatory Affairs, within Urovant’s Regulatory Affairs and Quality organization, is responsible for the development and implementation of regulatory affairs strategy as a member of multi-disciplinary pharmaceutical product development teams.
Key Duties and Responsibilities
- Represent the regulatory affairs function on assigned cross-functional small molecule and biologic pharmaceutical product development teams.
- Develop and implement global regulatory affairs strategy in accordance with applicable regulations/guidelines (e.g. US FDA, EMA, ICH, etc.) (for clinical trials and registration) for supported programs.
- Plan, prepare, author, and/or review submissions (e.g. IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
- May serve as primary liaison with FDA (and other health authorities, as appropriate) for day-to-day interactions.
- Coordinate and prepare responses to requests for information from health authorities.
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings with health authorities.
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
- Participate in due diligence evaluations of potential in-license/partnering opportunities.
Education and Experience
- Bachelor's degree required, with an advanced scientific degree (PhD, PharmD, MD) strongly preferred.
- 10 + years’ experience in Regulatory Affairs
Essential Skills and Abilities
- Regulatory Affairs experience in therapeutic areas of company focus.
- Regulatory Affairs experience with multiple therapeutic modalities; small molecules, biologics, gene therapies, drug/device combination products, and therapeutic devices.
- Ability to work effectively in a cross-functional team environment.
- Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables.
- Excellent written and oral communication skills.
- Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
- Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget.
- A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect.