Director, Regulatory Affairs-Pharma

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

• Oversee the coordination and preparation of high-quality submissions to regulatory authorities (e.g., briefing books, IND, CTA, NDA, amendments, supplements, annual reports, etc.) ensuring all regulatory requirements are met.
• Critical review of functional content provided by Subject Matter Experts for regulatory submissions.
• 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 technical issues, recommending and implementing well-designed solutions to resolve them.

Interact and Negotiate with Regulatory Agencies, Primarily US & EU, Regarding Strategy and Resolution of Complex Issues

• Point of contact for EMA on drug/device combination products and investigational new drugs.
• Interact and negotiate with EMA regarding strategy and resolution of complex issues.

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.
• Motivating the project team and assure their focus on departmental or project objectives.

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, adherence to style guide, and submission formats.
• Ensure that department management is aware of team activities and progress.

How will you get here?

• A Bachelor's degree in a scientific discipline from an accredited university is required. An advanced degree is preferred.
• 12 years of industry experience
• 4+ years of successful management experience in relevant industry
• A minimum of 5 years' experience in pharmaceuticals with 3-4 years' experience in Regulatory
• A minimum of 5 years of supervisory experience

Knowledge, skills, and abilities

• Experience in preparing and filing meeting packages, complete IND, A/NDA's, Supplements, Amendments and Annual Reports to competent authorities
• Thorough understanding of the CFR, FDA/ICH guidelines and cGMP's, as they pertain to pharmaceuticals
• Familiarity with EU guidelines relating to pharmaceuticals and experience with EMA or other regulatory agencies in Europe a plus
• 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 problem-solving skills
• Excellent written and verbal communication skills
• Excellent computer skills (Microsoft Office-Word, Excel, PowerPoint)
• Regulatory Affairs Certification (RAC) beneficial