Senior Manager, Regulatory Affairs (CMC)

About SpyGlass Pharma:

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn’t just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

We are seeking an experienced and strategic Senior Manager of Regulatory Affairs to join our team. In this role, you will partner with the SVP, Quality & Regulatory Affairs in developing and implementing regulatory strategies, with a significant emphasis on Chemistry, Manufacturing, and Controls (CMC) and later-stage development activities. This role will support the advancement of SpyGlass Pharma’s innovative ophthalmic drug-device combination products through clinical development. The successful candidate will address and resolve complex regulatory issues across CMC, preclinical, clinical, and commercial development programs while collaborating with interdisciplinary teams to ensure regulatory compliance and readiness for late-stage regulatory submissions.

Essential Duties & Responsibilities:

• Support the SVP, Quality & Regulatory Affairs to develop and implement regulatory strategies, primarily on drug-device combination products or prescription pharmaceuticals.
• Provide strategic regulatory guidance to cross-functional teams, ensuring alignment with FDA regulatory expectations and industry best practices.
• Lead the preparation, review, and submission of CMC sections for INDs, amendments, and clinical trial applications, meeting packages for FDA, EMA, technical files/design dossier and other regulatory agencies.
• Address and resolve complex regulatory issues related to CMC, including scale-up, technology transfer, process validation, and alignment with clinical development timelines.
• Proactively identify regulatory, quality, and technical issues and recommend / implement 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.
• 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.
• Interact and coordinate with R&D staff (CMC and Engineering) and consultants to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
• Monitor evolving global regulatory trends to prepare for future international submissions and provide insights for long-term strategic planning.
• Support the development of regulatory strategies for sustained-release drug delivery systems and combination products, ensuring adherence to Design Controls and applicable regulatory frameworks.
• Manage and maintain high-quality regulatory filings, including responses to agency questions, amendments, and annual reports, with a focus on timeliness and precision.
  

Qualifications Required For Position:

• Bachelor's degree in a relevant scientific discipline; advanced degree (e.g., Master's preferred.)
• 8-10 years of experience in regulatory affairs within the pharmaceutical industry, with a significant focus on CMC and late-stage development.
• Expertise in FDA regulatory requirements for CMC, including experience preparing and submitting INDs and other pre-commercial filings.
• Knowledge of US, EU, and international regulatory requirements and guidelines for drug/device combination products, including FDA/MOH regulations and FDA/ICH guidelines is strongly preferred.
• 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.
• Experience in regulatory strategy development, regulatory compliance, and leading regulatory activities for sustained release drug and drug/device combination products.
• 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.
  

Why SpyGlass Pharma?

• We are offering a range of $160,000 - $180,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the company’s future.
• Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
• Generous paid time off, including holidays, vacation days, and personal leave.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.

Salary : $160