Director, Regulatory Affairs
The Director, Regulatory Affairs (Pharmaceutical), based in San Clemente, CA is This position has the responsibility for developing and implementing global regulatory strategy, primarily on drug-device combination products, or prescription pharmaceuticals. S/he is also responsible for addressing and resolving regulatory issues in preclinical, CMC, clinical and commercial development programs. The position interacts with all levels in the organization, participating in discussions with management and providing strategic regulatory guidance.
• Provide Strategic Regulatory Guidance to Management and Inter-disciplinary Project Teams
• Serve as lead regulatory representative to provide effective regulatory leadership to CMC and clinical development teams for clinical stage products.
• Strong knowledge of FDA, EMA, ICH, cGMP and GxP strategies to ensure compliance with regulatory requirements for CMC and clinical development activities.
• Develop and implement global regulatory strategies and plans for projects at different phases of development.
• Provide regulatory review and approve internal documents supporting CMC and clinical development activities.
• Lead and manage the development and preparation of CMC and clinical related submission documents to support the filing and maintenance of IND, IMPD/eCTDs, and NDA.
• Apply expert strategic and scientific regulatory knowledge of product development to ensure compliance of global filing requirements for CMC and clinical studies.
• Interact and coordinate with R&D staff (CMC and Engineering) to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
• Prepare and File High-Quality Submissions to Regulatory Authorities
• Oversee the compilation and preparation of high-quality submissions to regulatory authorities (e.g., briefing books, IND, IMPD, CTA, NDA, amendments, supplements, annual reports, etc.) ensuring all regulatory requirements are met.
• Prepare driver reports for submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.
• Proactively identify regulatory, quality and technical issues and recommend and/or implement solutions to resolve them.
• Provide regulatory guidance on clinical safety reporting.
• Maintain accurate and timely regulatory records and logs.
• Interact and Negotiate with Regulatory Agencies, Primarily US & EU, Regarding Strategy and Resolution of Complex Issues
• Manage resolution and responses to queries from regulatory agencies (FDA and OUS).
• Manage import-export permits.
• Participate in regulatory meetings (FDA Type C and milestone meetings; EMA/Competent Authority scientific advice; PMDA official consultation meetings)
• Manage and Prioritize Assigned Projects in Accordance with Department and Company Goals
• Assist management in managing and prioritizing the team's workload in accordance with departmental goals.
• Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination.
• 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 pharmaceutical industry by actively participating in professional organizations.
• Ensure that department management is aware of team activities and progress.
• Develop staff and conduct quarterly check-in reviews, as applicable.
• Project professionalism and a courteous, cheerful and cooperative demeanor.
• Perform other duties as assigned.
• Minimum of 10 years of regulatory or related experience
• A minimum of 10 years' experience in pharmaceutical development with 5 years' experience in US regulatory development
• A minimum of 3 years of supervisory experience
Knowledge, Skills, and Abilities:
• Experience in preparing and filing US IND/amendments, annual reports and briefing books
• Knowledge of clinical study designs and protocols
• Significant knowledge of pharmaceutical development and CMC requirements for INDs
• Experience in addressing and drafting agency responses
• Thorough understanding of the CFR, FDA/ICH guidelines, GxP, and cGMP as they pertain to pharmaceutical development and manufacturing
• Knowledge of regulatory CMC and product development requirements at various stages of development
• Ability to understand and interpret complex scientific issues across different phases of development and provide regulatory guidance and support to development teams.
• Willingness to be part of a fast-paced organization and possessing a hands-on, roll-up-your-sleeves mentality
• Team player and adaptable, with strong technical and problem-solving skills
• Excellent written and verbal communication skills
• Excellent computer skills (Microsoft Office-Word, Excel, PowerPoint)
• Regulatory Affairs Certification (RAC) beneficial
• A Bachelor's Degree in a scientific discipline from an accredited university is required.
• An advanced degree is preferred.
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.
Back to top