As the Regulatory Affairs Specialist/Sr. Specialist, you’ll play a vital role in supporting the implementation of regulatory tasks including the preparation of program annual reports, regulatory filings, creation of department standard operating procedures, and much more!
Good things are happening at Omeros!
Come join our Regulatory Affairs Group!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
Supporting preparation of program annual reports as well as CMC, nonclinical, pharmacovigilance, and clinical regulatory filings
Conducting internet searches on regulatory topics to support development programs, and department and company compliance
Interacting with and having some oversight of vendor/contract research organization activities
Coordinating the drafting, editing and preparation of global regulatory submissions
Assisting in the creation of new or revision of existing department standard operating procedures
Managing regulatory tasks within time and budget of approved project plans
What experience, education and knowledge do you need?
You’ll need to have a minimum of a BS degree in a related field and 1 - 5 years of related experience and/or training, or an equivalent combination of education and experience in regulatory affairs; RAC (Regulatory Affairs Certified) certification is a plus.
Additionally, we are seeking candidates with the following knowledge:
A working knowledge of drug development guidelines and FDA regulations
Familiarity with EMA or other OUS regulatory systems is a plus
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
High detail orientation, excellent organizational and planning skills and the ability to prioritize multiple tasks
Strong computer application skills used in general office settings including word processing, spreadsheet, presentation software, and internet search engines
Demonstrated analytical and problem-solving skills
Demonstrated ability to identify issues and take appropriate action
A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.
Excellent interpersonal, verbal and written communication skills
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine ...and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission (EC) has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.