Regulatory Affairs Specialist

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Aliso Viejo, CA

Glaukos

<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4> https://www.glaukos.com/

keywords: position summary,teamwork,prepare,duties,planning,analysis,experience,knowledge,degree,communication

Full time

Overview: <p><strong>Glaukos is Growing! Join our Regulatory Affairs Team in our beautiful Aliso Viejo Campus&nbsp;</strong></p> <p><strong>How will you make an impact?</strong></p> <p>The&nbsp;<strong>Regulatory Affairs Associate, Regulatory Operations, Pharma</strong>&nbsp;based in Aliso Viejo, CA will work in partnership with the Regulatory Affairs, Pharma team to ensure the publication and submission of regulatory submission documents for drug-device combination products, or prescription pharmaceuticals (domestic and foreign). The Associate will be responsible for compilation and coordination of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory dossiers in compliance with applicable regulations and Glaukos internal processes. The position interacts cross-functional as needed for the type and content of the regulatory submissions and may interface with regulatory agencies (e.g., US FDA and EMA) and third vendors as it relates to its job duties.</p>
Responsibilities: <ul> <li>Participate in the preparation, review and submission of high-quality CTD/eCTD documents and materials to regulatory authorities (e.g., meeting requests, briefing books, INDs/IND amendments, NDA supplements, IMPDs, annual progress reports in different formats, etc.).</li> <li>Prepare submission content check list and eCTD Module 1</li> <li>Review eCTD submission materials (including documents, datasets and metadata) for completeness per regulatory requirements and the submission planner</li> <li>Perform final technical quality/pre-publishing review of eCTD section prior to final publication.</li> <li>Prepare and review regulatory&nbsp;submission planners and follow-up with team members, ensuring that Regulatory agency submission materials are complete and in compliance with regulatory standards.</li> <li>Provide guidance to inter-disciplinary project teams on regulatory submission requirements.</li> <li>Interact with Clinical,&nbsp;R&amp;D, QA, Operations staff to ensure compliance with regulatory submission requirements.</li> <li>Document Management and Preparation of Regulatory Documents in the Electronic Document Management System (eDMS) (Veeva Vault RIM) <ul> <li>Assign roles and responsibilities within the system and interact with third party vendor as needed to maintain and improve the functionality of the eDMS.</li> </ul> </li> <li>Archive regulatory correspondences and keep regulatory submission and correspondence logs up to date</li> <li>Keep Style Guide updated and enforce implementation across all regulatory submission documents, as appropriate.</li> <li>Must be able to plan and manage regulatory submission projects.</li> <li>Ensure that department management is aware of team activities and progress.</li> <li>Participate in company training programs that maintain appropriate awareness and compliance with ISO and CFR requirements.</li> </ul>
Requirements: <ul> <li>A Bachelor&rsquo;s Degree in a scientific discipline from an accredited university is required.</li> <li>A minimum of 2 years&rsquo; experience in Regulatory Affairs Operations.</li> <li>Understanding of regulatory and submission content for different submission types (e.g., IND, CTA, NDA, MAA) in CTD/eCTD structure.</li> <li>Demonstrate ability to ensure efficient electronic regulatory submissions in accordance with eCTD publishing software requirements for US FDA fillings; ex-US a plus.</li> <li>Familiarity with FDA&rsquo;s ESG, electronic drug establishment registration and drug listing, and navigation of FDA&rsquo;s Drug Approvals and Databases required.</li> <li>General understanding of the CFR, FDA/ICH guidelines and GxPs (i.e., cGMP, GLP, GCP) a plus.</li> <li>Experience with review and submission of promotional materials a plus.</li> <li>Good written and verbal communication skills.</li> <li>Proficient in Microsoft Office&mdash;Word, Excel, PowerPoint, Adobe Acrobat Pro, and eCTD publishing software).</li> <li>Experience with electronic document management systems (i.e., Veeva Vault RIM), Oracle and Microsoft Project Veeva a plus.</li> <li>Team player and adaptable, open to directions and constructive feed-back.</li> <li>Well organized, self-motivated and dependable.</li> </ul>