Sr. Manager, Regulatory Affairs
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.
The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
The Sr. Manager, Regulatory Affairs position, based in San Clemente, CA will have the responsibility for supporting the Sr. Director of Regulatory Affairs in developing and executing regulatory strategies primarily on drug-device combination products, or prescription pharmaceuticals. Position is also responsible for the on-time filing of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory dossiers. The position interacts with all levels in the organization. The Sr. Manager may interface with regulatory agencies, primarily the FDA and EMA, as it relates to submissions and other relevant topics.
PROVIDE STRATEGIC REGULATORY GUIDANCE TO MANAGEMENT AND INTER-DISCIPLINARY PROJECT TEAMS
• Provide guidance to inter-disciplinary project teams on regulatory requirements on projects at Phase 1 to IV of drug development/life cycle.
• Generate formal written regulatory strategy documents, primarily for combination drug-device products, but also for prescription pharmaceutical products. The strategy document should offer multiple potential solutions, but include a recommendation on the best option and why.
• Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance.
• Interact and coordinate with R&D staff to ensure compliance with regulatory requirements throughout drug development phases and to applicable Design Control Requirements (for device component of combination products).
PREPARE AND FILE HIGH-QUALITY SUBMISSIONS TO REGULATORY AUTHORITIES
• Compile and file high-quality CTD/eCTD submissions to regulatory authorities (e.g., briefing books, IND, CTN/CTA, NDA, IMPDs amendments, supplements, annual progress reports, etc).
• Prepare driver reports for submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.
• Maintain accurate and timely regulatory records and logs.
INTERACT AND NEGOTIATE WITH REGULATORY AGENCIES, PRIMARILY US & EU, REGARDING STRATEGY AND RESOLUTION OF COMPLEX ISSUES
• Interact with regulatory agencies (FDA, EMA) regarding regulatory submissions and agency queries.
MANAGE AND PRIORITIZE ASSIGNED PROJECTS IN ACCORDANCE WITH DEPARTMENT AND COMPANY GOALS
• Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination in contributing to regulatory submissions.
• Motivating the project team and assure their focus on departmental or project objectives and deliverables.
STAY ABREAST OF US & INTERNATIONAL REGULATORY INITIATIVES; CONTINUALLY INNOVATE AND ADAPT PRACTICES TO ENSURE BEST PRACTICES
• Stay current on new regulatory or other industry initiatives that could have a significant impact on the company's current or development products.
• Share best practices for planning, organization and time management.
• Gain deep insight into the industry (pharma and/or device) by actively participating in professional organizations.
• Ensure that department management is aware of team activities and progress.
• Project professionalism and a courteous, cheerful and cooperative demeanor.
• Perform other duties as assigned.
• A minimum of 7 years' experience in pharmaceuticals with 4-5 years' experience in Regulatory CMC and/or regulatory supporting development projects
• Demonstrated experience with health authority submissions (ie. INDs, Amendments, NDAs, CTAs, IMPD, MAA, etc.)
• Knowledge of regulatory requirements throughout clinical/drug development and lifecycle management
• Experience in representing regulatory affairs on development project teams
• Thorough knowledge of FDA regulations and guidance for pharmaceuticals products
• Knowledge of drug-device combination/device, international regulations/guidance a plus
• Excellent organizational, project management and writing skills with good understanding of drug development
• A Bachelor's Degree in a scientific discipline from an accredited university is required.
An advanced degree is preferred.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture.
Glaukos has been recognized for the second year in a row as a Top Workplace in Orange County! Check out a short video here.
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.
Location: Regulatory Affairs in San Clemente, CA
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