Job DetailsSr. Specialist, Regulatory OperationsPosition Summary: This position is responsible for assisting in the compilation of compliant paper and electronic regulatory submissions in addition to maintenance of regulatory department files including general regulatory agency correspondence.Good things are happening at Omeros!Come join our Omeros Regulatory Team!Who is Omeros? Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome, and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com .Essential Duties & Responsibilities:
- Plan, coordinate, archive and ensure high quality dossiers.
- Interact with internal departments to ensure timely submissions and to support global filings
- Collect documents for submissions as well as ensure compliance and formatting
- Work to achieve business objectives and priorities within Regulatory Operations with a specific focus on electronic document management, electronic regulatory submissions, submission tracking and other electronic systems
- Ensures documents for submission are compliant with e-submission and document style guide standards.
- Prepares submission forms required by global regulatory agencies.
- Maintains regulatory correspondence log.
- Maintain regulatory templates.
- Assists in training others on submission procedures and document formatting software tools.
- Maintains literature reference database.
- Performs other duties and responsibilities as required.
Experience and Education Required:
- Bachelor's degree (or equivalent) and a minimum of 5 years pharmaceutical or similarly regulated industry related experience
- Knowledge of eCTD publishing systems, EDMS and Regulatory tracking software
- General knowledge of drug development process and regulatory guidelines helpful
- Advanced computer application skills, including MS Office, Adobe Acrobat, and SharePoint skills
- Must be highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines.
- General knowledge of drug development process and regulatory guidelines is helpful
- Excellent verbal skills
- Strong problem-solving skills
Behavioral Competencies Required:
- The ability to build and maintain positive relationships with management, peers, and subordinates.
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
- May encounter prolonged periods of sitting.
Compensation and Benefits Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Sr. Specialist, Regulatory Operations role is $93,000 - $112,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit www.omeros.com.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to ...@omeros.com or contact Omeros, asking for Human Resources, at (206) ###-####.