Regulatory Affairs Specialist/Sr. Specialist
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 Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission 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 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 proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.
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 2 - 7 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
- Ability to represent Omeros in a professional manner
- Relocation assistance will be offered
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.