Sr. Director, Regulatory Affairs

Senior Director, Regulatory Affairs

This position is responsible for overseeing, supervising, and managing the Regulatory Affairs (RA) function. This includes Regulatory CMC, Regulatory Program Management, Regulatory Submissions, Regulatory Information, Technical Writing, and Pharmacovigilance. In addition to oversight and management of the RA function, this person will be responsible for developing and implementing the regulatory plan for key strategy and plan across programs.

Good things are happening at Omeros!

Come join our Omeros Regulatory Affairs & Quality Systems Team!

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

What are your job responsibilities?

• Supervises the activities of the RA team, which includes regulatory leads, technical writers, and pharmacovigilance coordinator
• Advises on the context and applicability of regulatory requirements for each program appropriate to the stage of product development
• Has oversight of coordination and preparation of regulatory submissions
• Ensures content and accuracy of regulatory filings
• Helps to develop regulatory strategy for programs
• Prepares cross-functional teams for regulatory interactions
• Develops, in conjunction with cross-functional team, regulatory strategy for development programs
• Ensures compliance with promotional and labeling regulatory requirements
• Interacts with domestic and foreign regulatory agencies on assigned projects
• Serves as the regulatory representative at project meetings and interacts with cross-functional team to achieve common goals
• Negotiates, interacts with, and supervises the activities of contract research organizations in the preparation of regulatory submissions, as necessary
• Develops and oversees the budget for regulatory affairs
• Communicates project status and issues to senior management in a timely manner

Education, Experience, Skills, and Knowledge Required:

• University degree and a minimum of 12 or more years related regulatory experience
• Knowledge of drug development process and regulatory guidelines
• Experience in oversight and management of a multifaceted department
• Direct experience in interacting with regulatory authorities and preparing cross-functional teams for such interactions
• Computer application skills: Advanced MS Office, Adobe Acrobat skills
• Excellent oral and writing skills, strong work ethic; leadership qualities

Behavioral Competencies Required: 

• Ability to build and maintain positive relationships with management, peers, and subordinates
• Display strong analytical and problem-solving skills

Other Requirements:

• Some projects (e.g., major submissions) may require workdays longer than 8 hours
• Work with Europe may require being available outside of core working hours on occasion

Physical Demands Required: 

• Intermittent physical activity including bending, reaching, pushing, or pulling
• May encounter prolonged periods of sitting

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