Senior Director of Regulatory Strategy

1 week ago


Aliso Viejo, California, United States Spyglass Pharma Full time
Job Overview

Salary Range: $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 in intraocular lens replacement. Our team is composed of experts in ophthalmic devices and drug delivery systems, working together to drive advancements in global eye care.

Our leadership team, with extensive experience in ophthalmology and product development, collaborates with skilled scientists and engineers to transform concepts into market-ready solutions. Our mission is rooted in enhancing patients' quality of life through continuous innovation.

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 involves addressing regulatory challenges throughout the product lifecycle, from preclinical to commercial stages, and requires interaction with all organizational levels to provide strategic regulatory insights.

Key Responsibilities:

  • Assist the VP of Regulatory Affairs in formulating and executing global regulatory strategies for drug-device combinations and pharmaceuticals.
  • Offer strategic regulatory advice to interdisciplinary project teams, ensuring alignment with FDA and international regulatory standards.
  • Identify potential regulatory and quality issues proactively, recommending and implementing effective solutions.
  • Engage in meetings with regulatory authorities, including FDA and EMA, to discuss development strategies and submissions.
  • Prepare and review regulatory documentation, including clinical trial applications and IND submissions.
  • Coordinate submission timelines and deliverables, ensuring compliance with established deadlines.
  • Work closely with cross-functional teams, including R&D and Clinical Operations, to maintain regulatory compliance throughout product development.
  • Collaborate with R&D personnel to ensure adherence to design control and pharmaceutical regulations.
  • Stay informed about evolving regulatory trends and provide guidance to senior management on compliance matters.

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, focusing on drug and combination products.
  • Comprehensive understanding of US, EU, and international regulatory frameworks.
  • Experience in preparing regulatory submissions and managing interactions with regulatory agencies.
  • Strong knowledge of pharmaceutical development processes and CMC requirements.
  • Proven success in regulatory submissions and agency interactions.
  • Excellent leadership and communication skills, with a collaborative approach to working with diverse teams.
  • Ability to thrive in a fast-paced environment while managing multiple projects effectively.

SpyGlass Pharma is an Equal Opportunity Employer and is committed to fostering a diverse workplace. We ensure that our hiring practices are free from discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.



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