How you will make an impact?
The Sr. Manager, Regulatory Affairs (Pharma) role based in San Clemente, CA, will have the responsibility for supporting the Sr./Director of Regulatory Affairs in developing and executing regulatory strategies primarily on drug-device combination products, or prescription pharmaceuticals. Position is also responsible for the on-time filing of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory dossiers. The position interacts with all levels in the organization. The Sr. Manager may interface with regulatory agencies, primarily the FDA and EMA, as it relates to submissions and other relevant topics.
What you will do?
PROVIDE STRATEGIC REGULATORY GUIDANCE TO MANAGEMENT AND INTER-DISCIPLINARY PROJECT TEAMS
- Provide guidance to inter-disciplinary project teams on regulatory requirements on projects at Phase 1 to IV of drug development/life cycle.
- Represent independently and proactively regulatory requirements and RA departmental positions to core/projects teams.
- 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.
- Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance and compilation of clinical submission documents.
- Interact and coordinate with R&D staff to ensure compliance with regulatory requirements throughout drug development phases.
- 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).
- Prepare submission content check list and eCTD Module
- Review Module 2 and Module 3 (including technical documents)
- Review Module 4 for completeness per regulatory requirements
- Review Module 5 i.e., clinical study reports and protocols
- 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.
- Maintain accurate and timely regulatory records and logs.
- Interact with regulatory agencies (FDA, EMA) regarding regulatory submissions and agency queries.
- Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination in contributing to regulatory submissions.
- Motivating the project team and assure their focus on departmental or project objectives and deliverables.
- Stay current on new regulatory or other industry initiatives that could have a significant impact on the company's current or development products.
- Share best practices for planning, organization and time management.
- Gain deep insight into the industry (pharma and/or device) by actively participating in professional organizations.
- Ensure that department management is aware of team activities and progress.
- Project professionalism and a courteous, cheerful and cooperative demeanor.
- Perform other duties as assigned.
- A minimum of 7 years' experience in pharmaceuticals with 4-5 years' experience in regulatory supporting development projects
- Demonstrated experience with health authority submissions (ie. INDs, Amendments, NDAs, CTAs, IMPD, MAA, etc.)
- Knowledge of regulatory requirements throughout clinical/drug development and lifecycle management
- Experience in representing regulatory affairs on development project teams
- Thorough knowledge of FDA regulations and guidance for pharmaceuticals products
- Knowledge of drug-device combination/device, international regulations/guidance a plus
- Excellent organizational, project management and writing skills with good understanding of drug development
- Experience with review and submission of promotional materials a plus
- Knowledge of post-marketing Pharmacovigilance a plus.
- Regulatory Affairs Certification (RAC) beneficial.
- A Bachelor's Degree in a scientific discipline from an accredited university is required.
- An advanced degree is preferred.
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're a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than 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.
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 paid time off & 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! Check out our profile on The Muse to get an inside look at our company culture. Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!
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.
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.
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-the iStent®-in the United States, followed by our next-generation iStent inject® device in September 2018.
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.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.