Job Description

Overview

Director/Sr. Director, Regulatory Affairs, CMC

This position is responsible for the CMC strategic regulatory direction, interactions with international regulatory agencies, regulatory CMC submissions, and operational CMC regulatory expertise to advance the companys drug candidates in accordance with current regulations and department procedures.

Responsibilities

• Develops / advises on the regulatory CMC strategy appropriate to the stage of product development.
• Implements strategy to advance projects through development to product registration.
• Drives content of CMC documentation to regulatory agencies (IND/IMPD; NDA/BLA/MAA), setting the standards for CMC regulatory submissions to assure quality, completeness, and regulatory accuracy.
• Coordinates with CMC, QA, and upper management for the preparation of CMC submissions through drafting, editing, and approval of final draft documents including review for quality.
• Coordinates preparation of information and related activities for CMC meetings with regulatory authorities.
• Advises upper management regarding strategic regulatory CMC topics.
• Serves as a bridge across the CMC, Regulatory Affairs, and QA functions.
• Leads the companys interactions with domestic and foreign regulatory agencies on CMC issues.
• Serves as the regulatory representative at project meetings.
• Interacts with contract manufacturing organizations in the preparation of regulatory submissions, as necessary.
• Manages regulatory CMC activities within time and budget for approved project plans.

Experience and Education

• BS, MS, or PhD in chemistry or other scientific discipline plus training in regulatory affairs.
• Minimum of 7 years in regulatory CMC.
• Experience interacting with major health agencies (e.g., FDA, Health Canada, EMA).

What Were Looking for in an Ideal Candidate

• Ability to provide regulatory CMC expertise and advice to upper management.
• Experienced in preparing / reviewing / approving regulatory CMC submissions.
• Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines.
• Good verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Ability to build and maintain positive relationships with management, peers, and subordinates.
• Strong work ethic.
• Excellent cross-functional leadership skills.

Other Requirements

• Overnight travel (10-15%).

Physical Demands

• 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 this position is (Director - $195,000 - $240,000; Sr Director $230,000 - $280,000). 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 visit

Equal Opportunity Employer

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.

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