We are a growing and dynamic organization seeking a Sr. Director, Regulatory Affairs to join our Regulatory Affairs team. In this position, you will be responsible for leading the Regulatory Affairs function. This includes Regulatory CMC, Regulatory managers, Regulatory Operations, Technical Writing, and Pharmacovigilance. In addition to oversight and management of the Regulatory Affairs function, you will be responsible for developing and implementing the regulatory plan for key programs.
Good things are happening at Omeros!
Come join our Regulatory Affairs Team!
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 intraocular solution) 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?
Your responsibilities in this position will include:
Supervising the activities of the Regulatory Affairs team, which includes Regulatory CMC, Operations, Technical/medical writing, Pharmacovigilance, and support
Advising on the context and applicability of global and national regulatory requirements for each program appropriate to the stage of product development
Providing strategic direction and oversight in the preparation of regulatory submissions
Ensuring content and accuracy of regulatory filings
Preparing cross-functional teams for regulatory interactions
Developing a regulatory strategy for development programs in conjunction with the cross-functional team
Ensuring compliance with promotional and labeling regulatory requirements
Interacting with domestic and foreign regulatory agencies on assigned projects
Serving as the regulatory representative at project meetings and interacting with cross-functional team to achieve common goals
Negotiating, interacting with, and supervising the regulatory activities of contract research organizations in the preparation of regulatory submissions
Developing and overseeing the budget for regulatory affairs
Communicating project status and issues to senior management
What education and experience do you need?
You’ll need to have a university degree and a minimum of 8 years of related regulatory experience
Experience in oversight and management of multifaceted department
Direct experience in interacting with regulatory authorities and preparing cross-functional teams for such interactions
Strong written and verbal communication skills with the demonstrated ability to communicate effectively and professionally
What knowledge and skills does our ideal candidate have?
Knowledge of the drug development process and global regulatory guidelines
Computer application skills: Advanced MS Office, Adobe Acrobat skills
Highly detail oriented, well organized with the ability to prioritize multiple tasks to meet deadlines
Excellent interpersonal and management skills with the ability to maintain positive relationships with management, peers, subordinates, and external organizations
Effective and clear communicator, verbally and in writing
Display strong analytical and problem-solving skills
Strong work ethic
Demonstrated leadership skills
Ability to adapt to change
Other things you need to know:
Some projects (e.g. major submissions) may require work days longer than 8 hours
Occasionally, work with Europe may require being available outside of core working hours
If you have the experience, skills and knowledge that we are seeking, we’d love to hear from you. This is an exciting opportunity for the right person!
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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.
Internal Number: 1193
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, Omer...os 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.