Director, Regulatory Affairs
2 weeks ago
About SpyGlass Pharma:
At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.
Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.
Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.
Learn more at www.spyglasspharma.com
Summary:
We are seeking an experienced Director of Regulatory Affairs to join our team at SpyGlass Pharma. This position has the responsibility for supporting the VP, Regulatory Affairs in developing and implementing global regulatory strategy, primarily on drug-device combination products, or prescription pharmaceuticals in the US, EU, and international markets. They will also be responsible for addressing and resolving regulatory issues in preclinical, CMC, clinical and commercial development programs. The position interacts with all levels in the organization, participating in discussions with management and providing strategic regulatory guidance.
Essential Duties & Responsibilities:
- Support the VP, Regulatory Affairs to develop and implement global regulatory strategies, primarily on drug-device combination products or prescription pharmaceuticals.
- Provide strategic regulatory guidance to interdisciplinary project teams, aligning with FDA/MOH regulatory requirements, FDA/ICH guidelines, and industry best practices.
- 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.
- Prepare and review of 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.
- 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).
- Stay abreast of regulatory trends, changes, and requirements in the pharmaceutical industry, providing strategic guidance and recommendations to senior management on regulatory matters.
Qualifications Required For Position:
- 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.
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.
-
Intern, Regulatory Affairs
1 week ago
Aliso Viejo, United States MicroVention Full timeJob Description Are you interested in working for an organization that is making a difference in people's lives every day? We're a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO...
-
Intern, Regulatory Affairs
2 months ago
Aliso Viejo, United States MicroVention Full timeAre you interested in working for an organization that is making a difference in people’s lives every day? We’re a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to...
-
Intern, Regulatory Affairs
1 week ago
Aliso Viejo, United States MicroVention Full time12152BR Title: Intern, Regulatory Affairs Job Description: Are you interested in working for an organization that is making a difference in people's lives every day? We're a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a...
-
Specialist I, Regulatory Affairs
4 weeks ago
Aliso Viejo, United States MicroVention Full timeJob Description This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties: Serves as a member on project teams completing tasks as assigned by the team. Aides in the execution of the regulatory...
-
Associate Director, Pharmaceutical Development
2 weeks ago
Aliso Viejo, United States Spyglass Pharma Full timeJob Description Job Description Salary: $150k - $175k About SpyGlass Pharma: At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Associate Director, Analytical R&D
3 days ago
Aliso Viejo, United States Spyglass Pharma Full timeJob Description Job Description Salary: $150k - $175k About SpyGlass Pharma: At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Associate Director, Pharmaceutical Development
2 weeks ago
Aliso Viejo, United States Spyglass Pharma Full timeJob DescriptionJob DescriptionSalary: $150k - $175kAbout SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Associate Director, Analytical R&D
2 weeks ago
Aliso Viejo, United States Spyglass Pharma Full timeJob DescriptionJob DescriptionSalary: $150k - $175kAbout SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Director, Clinical Compliance
1 week ago
Aliso Viejo, United States Glaukos Full timeGLAUKOS #DareToDomore Director, Clinical Compliance Founded in 1998, Glaukos is publicly traded ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Our global headquarters is in Aliso Viejo, California, and we have additional...
-
Director of Quality Assurance
1 month ago
Aliso Viejo, United States Spyglass Pharma Full timeJob Description Job Description Salary: $175k/yr - $225k/yr You're a seasoned leader in Quality Assurance, boasting a pharmaceutical industry background, and who is: Excited about joining a talented team with significant progress toward bringing an revolutionary, life-changing product to market Ready to lead quality initiatives in a dynamic, innovative...
-
Director, Quality Assurance
2 weeks ago
Aliso Viejo, United States Spyglass Pharma Full timeJob DescriptionJob DescriptionSalary: $175k/yr - $225k/yrAbout SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Director, Quality Assurance
1 week ago
Aliso Viejo, United States Spyglass Pharma Full timeJob DescriptionJob DescriptionSalary: $175k/yr - $225k/yrAbout SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Senior R&D Analytical Chemist
2 months ago
Aliso Viejo, United States RXSIGHT INC Full timeJob DescriptionJob DescriptionDescription:RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by...
-
Director of Compensation
1 week ago
Aliso Viejo, United States HR Recruiting Firm Full timeWe are seeking a highly skilled and experienced Director of Compensation to lead our client's compensation team. The ideal candidate will have a strong background in compensation strategy development, implementation, and management. They will be responsible for designing and administering competitive and effective compensation programs that attract, retain,...
-
Director, Quality Assurance
2 weeks ago
Aliso Viejo, United States Spyglass Pharma Full timeJob DescriptionJob DescriptionSalary: $175k/yr - $225k/yrAbout SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care. Our team comprises professionals with diverse expertise in ophthalmic devices and drug...
-
Engineering Manager, R&D
2 weeks ago
Aliso Viejo, United States MicroVention Full timeJob Description Manage individuals from entry-level to junior-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties: Manage a group of individuals of varying...
-
Manager, Engineering R&D
4 weeks ago
Aliso Viejo, United States MicroVention Full timeJob Description Manage individuals from entry-level to junior-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties: Manage a group of individuals of varying...
-
Engineering Manager, R&D
4 days ago
Aliso Viejo, United States MicroVention-Terumo Full timeEngineering Manager, R&D Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed. Working for a company voted Great Places to Work - 2022, the Engineering Manager, R&D will manage individuals from entry-level to junior-level experience, develop and launch products, research new...
-
Associate Engineering Manager, R&D
5 days ago
Aliso Viejo, United States MicroVention-Terumo Full timeAssociate Engineering Manager, R&DWorking for a company voted Great Places to Work - 2022, the Associate Engineering Manager, R&D will manage individuals from entry level to junior level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the...
-
Engineering Manager, R&D
5 days ago
Aliso Viejo, United States MicroVention-Terumo Full timeEngineering Manager, R&DWorking for a company voted Great Places to Work - 2022, the Engineering Manager, R&D will manage individuals from entry-level to junior-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the...
