Sr. Manager/Associate Director, Regulatory Affairs

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Job description

Position Summary:

The Sr. Manager/Associate Director, Regulatory Affairs is responsible for regulatory leadership and strategy for multiple development programs and for contributing to the lifecycle development of clinical and commercial program across various disease areas.

Who is Omeros?

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, as well as cancers and addictive and compulsive disorders. 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. Omeros' long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 multi-ascending-dose clinical trial. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder and, in addition, is being developed as a therapeutic for other addictions as well as for a major complication of treatment for movement disorders. Omeros also is advancing a broad portfolio of novel immuno-oncology programs comprised of two cellular and three molecular platforms. For more information about Omeros and its programs, visit .

Good things are happening at Omeros!

Come join our Omeros Regulatory team!

Essential Duties & Responsibilities:

• Advising on the context and applicability of global and national regulatory requirements for development programs appropriate to the stage of product development
• Providing leadership and mentoring to department staff with emphasis on development and integration of regulatory plans and strategies for products in early development through post- commercialization
• Serving as the regulatory representative at project meetings and interacting with cross- functional team to achieve common goals
• Being the lead author on key regulatory submissions (e.g., briefing documents, applications for expedited programs)
• Developing a regulatory strategy for assigned development programs in conjunction with the cross-functional team
• Interacting with domestic and foreign regulatory agencies on assigned projects
• Preparing cross-functional teams for regulatory interactions
• Providing strategic direction for regulatory submissions
• Ensuring content and accuracy of regulatory submissions for assigned development programs
• Negotiating, interacting with, and supervising the regulatory activities of contract research organizations in the preparation of regulatory submissions for assigned development programs
• Communicating project status and issues to senior management
• Other relevant duties as assigned

Education, Experience, Knowledge, and Skills:

• A BS degree and a minimum of 7 years of related experience in the pharmaceutical industry for a Sr. Manager level and a minimum 10 years of experience in the pharmaceutical industry for an Associate Director level
• Experience in oversight and management of development programs
• 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
• Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
• Excellent teamwork and collaboration capabilities
• Knowledge of the drug development process and global regulatory guidelines
• Computer application skills: Advanced MS Office, Adobe Acrobat skills
• Excellent interpersonal and management skills with the ability to maintain positive relationships with management, peers, subordinates, and external organizations
• Display strong analytical and problem-solving skills

Behavioral Competencies:

• Strong work ethic
• Demonstrated leadership skills
• Ability to adapt to change
• Integrity
• Ability to represent Omeros in a professional manner

Other Requirements:

• Some periods (e.g., major submissions) may require work days longer than 8 hours
• Occasionally, work with international vendors may require being available outside of core working hours
• Occasional overnight and/or international travel

Physical Demands Required:

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
• May encounter prolonged periods of sitting.

Compensation and Benefits

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Sr. Manager/Associate Director, Regulatory Affairs role is $155,000 - $205,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit .

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 or contact Omeros, asking for Human Resources, at .

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