- 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.
- 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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Director, Regulatory Affairs - Aliso Viejo, United States - Spyglass Pharma
Description
Job Description
Job DescriptionSalary: $175k - $215kAbout 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 PharmaTM 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
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:
Qualifications Required For Position:
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 .COM and let us know the nature of your request and your contact information.
