Regulatory Affairs Manager - Pharma

<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> <br /><br />Base Salary Range: $109,100 - $141,800

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,compensation,analysis,prepare,quality assurance,planning,teamwork,compliance,communication,knowledge,experience,education,skills,certification

Full time

Base Salary Range: $109,100 - $141,800

Overview: Provide guidance to inter-disciplinary project teams on regulatory requirements on projects at Phase 1 to 4 of drug development/life cycle.&nbsp;Compile and file high-quality CTD/eCTD submissions to regulatory authorities (e.g., briefing books, INDs and IND amendments, NDAs and NDA supplements, CTN/CTA, IMPDs, annual progress reports in different formats etc).
Responsibilities: <p><strong>PROVIDE STRATEGIC REGULATORY GUIDANCE TO MANAGEMENT AND INTER-DISCIPLINARY PROJECT TEAMS</strong></p> <ul> <li>Represent independently and proactively regulatory requirements and RA departmental positions to core/projects teams.</li> <li>Generate formal written regulatory strategy documents, primarily for combination drug-device products, but also for prescription pharmaceutical products. The strategy document should offer multiple potential solutions but include a recommendation on the best option and why.</li> <li>Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance and compilation of clinical submission documents.</li> <li>Interact and coordinate with R&amp;D staff to ensure compliance with regulatory requirements throughout drug development phases.&nbsp;</li> </ul> <p><strong>PREPARE AND FILE HIGH-QUALITY SUBMISSIONS TO REGULATORY AUTHORITIES</strong></p> <ul> <li>Prepare submission content check list and eCTD Module 1</li> <li>Review Module 2 and Module 3 (including technical documents)</li> <li>Review Module 4 for completeness per regulatory requirements</li> <li>Review Module 5 i.e., clinical study reports and protocols.</li> <li>Hold submission kick-off meetings (KOMs) and prepare driver reports for submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.</li> <li>Maintain accurate and timely regulatory records and logs.</li> </ul> <p><strong>INTERACT WITH REGULATORY AGENCIES, PRIMARILY US &amp; EU, REGARDING STRATEGY AND RESOLUTION OF COMPLEX ISSUES</strong></p> <ul> <li>Interact with regulatory agencies (i.e., FDA, EMA) to facilitate the review and approval regulatory submissions and resolution of agency queries.&nbsp;</li> </ul> <p><strong>MANAGE AND PRIORITIZE ASSIGNED PROJECTS IN ACCORDANCE WITH DEPARTMENT AND COMPANY GOALS</strong></p> <ul> <li>Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination in contributing to regulatory submissions.&nbsp;</li> <li>Motivating the project team and assure their focus on departmental or project objectives and deliverables.</li> </ul> <p><strong>STAY ABREAST OF US &amp; INTERNATIONAL REGULATORY INITIATIVES; CONTINUALLY INNOVATE AND ADAPT PRACTICES TO ENSURE BEST PRACTICES</strong></p> <ul> <li>Stay current on new regulatory or other industry initiatives that could have a significant impact on the company&rsquo;s current or development products.</li> <li>Share best practices for planning, organization and time management.</li> <li>Gain deep insight into the industry (pharma and/or device) by actively participating in professional organizations.&nbsp;</li> <li>Ensure that department management is aware of team activities and progress.</li> <li>Project professionalism and a courteous, cheerful and cooperative demeanor.</li> <li>Perform other duties as assigned.</li> </ul>
Requirements: <ul> <li>A Bachelor&rsquo;s Degree in a scientific discipline from an accredited university is required.</li> <li>An advanced degree is preferred.</li> <li>A minimum of 6 years in pharmaceuticals with 4 years of experience supporting regulatory submissions in drug development.</li> <li>Demonstrated experience with health authority submissions in CTD format Modules 1-5 (i.e., INDs, amendments/supplements, NDAs, CTAs, IMPD, MAA, etc.).</li> <li>Knowledge of regulatory requirements (FDA/EMA regulations/guidance and ICH guidelines) throughout clinical/drug development and lifecycle management for pharmaceuticals products.</li> <li>Experience in representing regulatory affairs on development project teams.</li> <li>Thorough understanding of GxPs (i.e., cGMP, GLP, GCP).</li> <li>Background in Clinical regulatory affairs: Clinical study reports, protocols, Investigator Brochure, investigator updates, ICF, IRB, site initiation, sponsor/investigator responsibilities etc.</li> <li>Knowledge of drug-device combination/device, international regulations/guidance a plus.</li> <li>Excellent organizational, project management and writing skills with good understanding of drug development.</li> <li>Experience with review and submission of promotional materials a plus.</li> <li>Knowledge of post-marketing Pharmacovigilance a plus.</li> <li>Regulatory Affairs Certification (RAC) beneficial.</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;&nbsp;</p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.&nbsp;</p> <p>Those may seem like big aspirations, but 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 eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.&nbsp;</p> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Glaukos Corporation has been Certified as a Great Place to Work the last two years!&nbsp;</p> <p>Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.&nbsp;</p>