Reporting to the Sr. Director, Regulatory Affairs, you’ll be responsible for managing and implementing the regulatory development plan for assigned programs ensuring they are in compliance with regulatory requirements.
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?
Advising on the context and applicability of functional regulatory requirements for each assigned program appropriate to the stage of product development
Coordinating the drafting, editing and preparation of regulatory submissions
Ensuring the content and accuracy of regulatory fillings
Overseeing and ensuring that the regulatory files and systems are maintained in accordance with department procedures, compliance standards, laws, and regulations
Interacting with domestic and foreign regulatory agencies on assigned projects
Serving as the regulatory representative at project meetings and interacting with personnel from corporate partners in order to achieve common goals
Negotiating, interacting with, and supervising the activities of contract manufacturing organizations (CMO’s) in the preparation of regulatory submissions
Managing regulatory tasks within time and budgets for approved project plans
Communicating project status and issues
Supervising the activities of regulatory associates and assistants
What experience and education do you need?
You’ll need to have a BS/MS degree in a life science or a related field with a minimum of 5 – 7 years of regulatory affairs experience working in a biopharma as well as a minimum of 2 years in drug development.
Additionally, we are seeking candidates with the following experience and knowledge:
Drug development process
What skills and knowledge does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
Drug development process knowledge
Regulatory guidelines knowledge
Demonstrated ability to lead and manage projects
Strong analytical and problem solving skills
Excellent organizational skills with a high level of accuracy and detail orientation
Demonstrated ability to handle multiple competing priorities, prioritize multiple tasks, and utilizing resources effectively
A demonstrated ability to build and maintain positive relationships both internally and externally
Excellent interpersonal, verbal and written communication skills
Leadership qualities: ethics, integrity, creativity, collaboration, etc.
Advanced computer application skills in MS Office and Adobe Acrobat.
What else do you need to know?
You’ll be required to travel approximately 20% of the time including both overnight domestic and international travel
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.