As the Regulatory Affairs CMC Sr. Manager or Director, you’ll be responsible for the CMC strategic regulatory direction and operational CMC regulatory expertise, advancing the company’s drug candidates in accordance with current regulations and department procedures.
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?
Contributing to the development of CMC regulatory strategy appropriate to the stage of product development
Implementing strategy to advance projects through development to product registration
Driving content of CMC documentation to regulatory agencies (IND/CTA; NDA/MAA), setting the standards for CMC regulatory submissions
Coordinating the preparation of CMC submissions through editing and approval of final draft documents including review for quality
Coordinating preparation of information and related activities for CMC meetings with health authorities
Interacting with domestic and foreign regulatory agencies on CMC issues
Serving as the regulatory representative at project meetings and interacts 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 CMC activities within time and budgets for approved project plans
Communicating project status and issues
What experience and education do you need?
You’ll need to have a BS/MS degree in Chemistry or other scientific discipline plus training in regulatory affairs with 10+ years of related experience and/or training in the pharmaceutical industry with a minimum of 5 years in CMC regulatory.
Additionally, we are seeking candidates with the following experience:
Significant experience interacting with at least one major health agency (FDA, Health Canada or EMA); interactions with one or more major health agencies desired
Experience in preparing/reviewing regulatory IND/CTA and CTD NDA paper and/or electronic submissions
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
A comprehensive understanding of CMC regulatory requirements including FDA and ICH guidelines and relevant government regulations as they apply to the registration, development and approval of investigational products as well as post approval changes to marketed products
A demonstrated ability to contribute regulatory CMC expertise and advice
Demonstrated analytical and problem solving skills
Detail orientation, organizational skills and the ability to prioritize multiple tasks
A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.
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 10% of the time
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.