Regulatory Affairs Director

2 days ago

Aliso Viejo, California, United States Spyglass Pharma Full time
Job Title: Director of Regulatory Affairs

At SpyGlass Pharma, we are seeking an experienced Director of Regulatory Affairs to join our team. This position will support the VP, Regulatory Affairs in developing and implementing global regulatory strategies for drug-device combination products and prescription pharmaceuticals in the US, EU, and international markets.

Key Responsibilities:
  • Develop and implement global regulatory strategies for drug-device combination products and prescription pharmaceuticals.
  • Provide strategic regulatory guidance to interdisciplinary project teams, aligning with FDA/MOH regulatory requirements and industry best practices.
  • Proactively identify regulatory, quality, and technical issues and recommend solutions to resolve them.
  • Participate in FDA and HA meetings, including FDA Pre-IND, EOP2, EOP3, Pre-NDA, Type C/D meetings, Pre-Sub meetings, EMA Scientific Advisory meetings.
  • Prepare and review regulatory submissions, including clinical trial applications, IND, meeting packages for FDA, EMA, technical files/design dossier, and other regulatory agencies.
  • Manage and facilitate submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.
  • Collaborate closely with cross-functional teams, including R&D, Clinical Operations, Quality Assurance, and Clinical teams, to ensure regulatory compliance and successful product development.
  • Stay abreast of regulatory trends, changes, and requirements in the pharmaceutical industry, providing strategic guidance and recommendations to senior management on regulatory matters.
Requirements:
  • Bachelor's degree in a relevant scientific discipline; advanced degree (e.g., Master's preferred).
  • Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on drug and drug/device combination products.
  • In-depth knowledge of US, EU, and international regulatory requirements and guidelines for drug and drug/device combination products, including FDA/MOH regulations and FDA/ICH guidelines.
  • Experience in preparing and filing US IND/amendments, annual reports, and briefing books.
  • Knowledge of pharmaceutical development and CMC requirements for INDs.
  • Thorough understanding of the CFR, FDA/ICH guidelines, GxP, and cGMP as they pertain to pharmaceutical development and manufacturing.
  • Knowledge of design controls, device development (Class III), and drug-device combination product development a plus.
  • Knowledge of regulatory CMC and product development requirements at various stages of development.
  • Proven track record of successful regulatory submissions, meetings, and interactions with regulatory agencies.
  • Strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
  • Experience in regulatory strategy development, regulatory compliance, and leading regulatory activities for sustained release drug and drug/device combination products.
  • Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.

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