Senior Director - Regulatory Affairs

We are a fast-growing and dynamic organization seeking a Director/Senior Director, Regulatory Affairs to join our team. This position is responsible for regulatory leadership strategy, and supervision for multiple development programs and for contributing to the lifecycle development of clinical and commercial programs across various disease areas.

Good things are happening at Omeros!

Who is Omeros?

Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA^® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit www.omeros.com.

What are your job 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, mentoring, and supervision to department staff with emphasis on development and integration of regulatory plans and strategies for products in early development through post- commercialization

• Developing a regulatory strategy for assigned development and commercial programs in conjunction with the cross-functional team

• Being the lead author on key regulatory submissions (e.g., briefing documents, applications for expedited programs)

• Serving as the regulatory representative at project meetings and interacting with cross- functional team to achieve common goals

• Working closely with Regulatory Medical Writing and Regulatory Operations to ensure timely and accurate regulatory submissions

• 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 and commercial 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

What education and experience do you need?

Required

• A BS degree and a minimum of 10 years of related experience in the pharmaceutical industry for a Director level, and a minimum 14 years of related experience in the pharmaceutical industry for a Senior Director level (RAC Certification a plus)
• Experience indeveloping and managing regulatory strategy of development programs
• Material and 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
• Seasoned 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 Required:

• Strong workethic

• Demonstrated leadershipskills

• Flexibility and ability to adapt tochange

• Strong and agile problem-solving skills

• Integrity

• Ability to represent Omeros in a professionalmanner

Other Requirements:

• Some periods (e.g., major submissions) may require work days longer than 8 hours

• Occasionally, interactions with international vendors and/or regulatory agencies may require being available outside of core working hours

• Occasional overnight and/or international travel

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 this position (Director = $195,000 - $245,000; Sr Director= $225,000 - $260,000). 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 incentive and stock options. To learn more about Omeros, please visitwww.omeros.com.

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 protected]