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Head of Regulatory Affairs
2 months ago
Salary: $175k - $215k
About SpyGlass Pharma:
SpyGlass Pharma is dedicated to addressing critical needs in the fields of glaucoma and cataract surgery, focusing on innovative solutions that enhance global eye care.
Our team is composed of experts in ophthalmic devices and drug delivery systems, with a leadership group that boasts extensive experience in ophthalmology, intraocular lens (IOL) development, and successful commercialization. Our approach transforms ideas from concept to market, driven by a commitment to improving patient outcomes.
Position Summary:
We are looking for a seasoned Director of Regulatory Affairs to oversee the development and execution of comprehensive global regulatory strategies, particularly for drug-device combination products and prescription pharmaceuticals across various markets including the US and EU. This role will involve navigating regulatory challenges throughout preclinical, CMC, clinical, and commercial development phases, while providing strategic regulatory insights to all organizational levels.
Key Responsibilities:
- Assist the VP of Regulatory Affairs in formulating and executing global regulatory strategies focused on drug-device combination products and prescription medications.
- Deliver strategic regulatory advice to cross-functional project teams, ensuring alignment with FDA and international regulatory standards.
- Identify potential regulatory, quality, and technical challenges proactively, and propose effective solutions.
- Engage in discussions with regulatory agencies, including FDA and EMA, to facilitate the approval process.
- Prepare and review regulatory submissions, such as clinical trial applications and INDs, ensuring compliance with all regulatory requirements.
- Coordinate submission timelines and deliverables, collaborating with team members to meet established deadlines.
- Work closely with various departments, including R&D and Clinical Operations, to maintain regulatory compliance throughout product development.
- Stay informed about evolving regulatory trends and requirements, providing guidance to senior management on relevant issues.
Qualifications:
- Bachelor's degree in a relevant scientific field; advanced degree preferred.
- At least 10 years of experience in regulatory affairs within the pharmaceutical sector, emphasizing drug and drug-device combination products.
- Comprehensive understanding of US, EU, and international regulatory frameworks.
- Experience in preparing and submitting INDs and related documentation.
- Strong knowledge of pharmaceutical development processes and CMC requirements.
- Proven success in managing regulatory submissions and interactions with regulatory bodies.
- Excellent leadership and communication skills, with a proven ability to collaborate across diverse teams.
- Ability to thrive in a fast-paced environment while managing multiple projects effectively.
SpyGlass Pharma is an Equal Opportunity Employer and values diversity in the workplace.
