Regulatory Affairs Specialist

The Regulatory Specialist provides support by helping to develop and execute against regulatory plans for one or more products. You will provide support to the implementation of regulatory tasks ensuring compliance to applicable regulatory requirements and regulations (e.g., FDA, EMA, and ICH) and well as scientific and company policies and department procedures.

Good things are happening at Omeros!

Come work with 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 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?

Your responsibilities in this position will include:

• Supports preparation and maintenance of program annual reports, and may support CMC, nonclinical, pharmacovigilance and other routine regulatory programs. and other routine regulatory filings.

• Conducts internet searches on regulatory topics to support development programs, and department and company compliance.

• Provides technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.

• Coordinates, prepares, or reviews regulatory submissions for domestic and/or international projects.

• If supporting a marketed product, reviews product promotional materials and labeling for compliance with applicable regulations and policies.

• Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, as well as clarification and follow-up of submissions under review.

• Ensures compliance with applicable regulations and guidelines (e.g., FDA, EMA, ICH).

• Interacts with and may have some oversight of vendor/contract research organization activities.

• Escorts government inspectors during inspections and provides post-inspection follow-up information as requested.

• Interprets regulatory rules or rule changes and ensures they are incorporated into corporate policies and procedures as appropriate.

• Assists in writing or updating standard operating procedures, work instructions, or policies.

• Advises project teams on subjects such as premarket regulatory requirements, labeling requirements, or clinical study regulatory compliance issues.

• Identifies relevant guidance documents, international standards, or consensus standard and provides interpretive assistance.

• Participates in internal or external audits.

• Reviews clinical protocols to ensure collection of data needed for regulatory submissions.

• Coordinates recall or market withdrawal activities as necessary.

• Manages regulatory tasks within time and budget of approved project plans.

• Bachelor's degree in a related field; advanced degree desirable; RAC certification desirable. A minimum of two years of relevant experience in Regulatory Affairs with drug or therapeutics biologic products.

• Working knowledge of drug development guidelines and FDA regulations.

• Familiarity with EMA or other OUS regulatory systems.

• Strong organizational skills to maintain a high level of productivity, innovation, and prioritization under tight timelines.

• Excellent oral and written communication skills, including the ability to assist with the preparation of responses to health authority requests

• Strong proficiency with Microsoft Office suite including Word, Excel, and Power Point as well as Adobe Acrobat

• Creativity and problem-solving skills

• Must represent Omeros in a professional manner

• Good organizational and planning skills.

• Demonstrated ability to identify issues and take appropriate actions.

• The ability to build and maintain professional relationships with management, peers, and subordinates.

• Attention to detail required.

• May frequently be performing repetitive movements such as typing on a keypad or using a mouse

• May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch

• On occasion must lift and/or move up to 25 pounds

If you have the skills, knowledge and experience we are seeking, 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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.