What are the responsibilities and job description for the Director, Regulatory Affairs position at Glaukos?
Job Description
GLAUKOS DIRECTOR REGULATORY AFFAIRS
How will you make an impact?
This position is responsible for implementing regulatory strategy for drug-device combination products and prescription pharmaceuticals. This individual is also responsible for the on-time filing of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory documents. The position interacts cross-functionally within the organization, participating in discussions with management and providing strategic regulatory guidance and owning the creation of content for regulatory submissions.
What will you do?
Provide Strategic Regulatory Guidance to Interdisciplinary Project Teams
- Oversee, critically review, and create content for drug / device combination product regulatory submissions to US FDA and globally.
- Provide expert regulatory strategy / guidance to staff and inter-disciplinary project teams.
- Implement and execute global regulatory strategies and plans for drug / device combination products.
- Provide regulatory review and approve internal documents supporting product development activities.
- Apply expert knowledge of product and industry best practices, and / or critical thinking.
- Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance.
- Interact and coordinate with R&D staff to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug / device combination products).
- Mentor regulatory team members
Prepare and File High-Quality Submissions to Regulatory Authorities
Interact and Negotiate with Regulatory Agencies, Primarily US & EU, Regarding Strategy and Resolution of Complex Issues
Manage and prioritize assigned projects in accordance with department and company goals
Stay abreast of US & international regulatory initiatives; Continually Innovate and Adapt Practices to Ensure Best Practices
How will you get here?
Knowledge, skills, and abilities
GKOSUS
About Us
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity / Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
