Address
Form of workSr. Specialist, Regulatory Affairs CMC
Position Summary:
This position is primarily responsible for preparation, review, and compilation of CMC filings in support of commercial and clinical applications in accordance with ICH requirements, regional requirements, and scientific and company policies and procedures.
Good things are happening at Omeros!
Come join our Omeros CMC Team!
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 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?
- Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy
- Review and edit final documents for regulatory CMC submissions in a timely manner
- Prepare information and related activities for CMC meetings with health authorities
- A solid understanding of CMC regulatory requirements including FDA and ICH guidelines for large and small molecule products as they apply to post-approval changes to marketed products as well as the registration, development, and approval of investigational products
- Stay up to date on knowledge of regulatory requirements, including CMC and general regulatory, and communicates changes in regulatory information to full regulatory team as well as project teams in a timely manner
- Maintain current awareness of evolving regulatory environment including advisory letters, enforcement letters and policy issues
- Participate, as needed, in local and/or global submission process to assist in the overall efficiency of the regulatory submission process
- Manage regulatory CMC activities within time and budget for approved project plans
- Help define and implement strategic regulatory CMC activities across programs
Education, Experience, Skills & Knowledge Required:
- Degree in Chemistry or other scientific discipline, MS preferred, plus training in Regulatory Affairs
- 5 years or greater experience in the pharmaceutical industry with a minimum of 2 years in CMC regulatory, including working on biologics
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Good verbal and written skills
- Strong analytical and problem-solving skills
- Strong work ethic
- Computer application skills: Advanced MS Office, Adobe Acrobat skills
Behavioral Competencies Required:
- The ability to build and maintain positive relationships with management, peers, and subordinates
Physical Demands Required:
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. Specialist, Regulatory Affairs CMC is $90,000 - $115,000. 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 www.omeros.com.
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 tohr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.
