Manager, Regulatory Affairs, Promotions & Advertising

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Job description

Manager Regulatory Affairs, Advertising and Promotion

Good things are happening at Omeros!

Come join our Regulatory & Quality Systems Team!

The Manager of Regulatory Affairs, Advertising and Promotion reports to the Director, who is responsible for the Commercial Regulatory function. As a Manager, you are accountable for all operational aspects of Regulatory Advertising/Promotion providing planning and technical support for the Company's products.

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

Job Responsibilities:

• Responsible for running the process including facilitation of review and tracking of all materials throughout the review and approval process in collaboration with Commercial Operations and closely interacting with relevant departments, teams and agencies
• Manage proofing for print and digital production materials within the scientific principles of regulatory/quality reviews
• Submission activities for pre-clearance and 2253, "time of first use" submissions and also regulatory activities involved with a new product launch
• Providing strategic regulatory advice on advertising and promotional materials and activities in accordance with business goals and objectives, FDA regulations/guidelines, PhRMA guidelines, and company policy
• Serve as regulatory submissions liaison to FDA/CDER/OPDP for assigned products, as a single point of contact for the compilation, submission, tracking, approvals and review of Form 2253 to transfers for FDA's Office of Prescription Drug Promotion submission
• Check data sources supporting Advertising and Promotional materials and labeling claims, history of labeling negotiations and changes
• Manage proofing of print and digital materials for production
• Supports goals and prioritize workload with Commercial Operations, reflecting clear alignment with the Commercial organization's strategic priorities
• Establishes collaborative relationships with the Commercial Operations/Marketing team and agencies through frequent communication and interaction to understand needs and optimize effectiveness
• Provide notification of FDA submission of materials to project originators and maintain Activity Tracker for FDA-OPDP submissions
• Ensures the appropriate and timely review and approval of any generated materials in accordance with relevant SOPs and local laws/codes of practice
• Candidate to assist with additional regulatory projects as needed

E ducation, Experience, Skills, and Knowledge Required:

• Bachelor's degree required, higher degree with clinical and scientific training will be an advantage (MS, PharmD, PhD, RN)
• 5 years of experience in Regulatory Affairs Advertising & Promotion (desirable)
• Experience in leading activities for pre-clearance and 2253, "time of first use" submissions (desirable)
• Experience with regulatory activities involved with a product launch (desirable)
• Strong ability to work with cross-functional teams
• Strong project management skills with the ability to collaborate and manage with all stakeholders to adhere to timelines and deadlines; work independently on assigned projects within timelines
• Great attention to detail and ability to interpret clinical and scientific data is required
• Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment

Behavioral Competencies Required:

• Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
• Integrity

Physical Demands Required

• May encounter prolonged periods of sitting or standing

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 .