Specialist/Sr. Specialist Regulatory Affairs/CMC
Regulatory Affairs CMC Specialist/Sr. Specialist
This position is primarily responsible for coordinating the preparation, review, and compilation of CMC filings in support of commercial 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 Regulatory Affairs Team!
About Omeros Corporation
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?
- Creates/compiles content of CMC documentation to regulatory agencies (NDA/MAA), setting the standards for CMC regulatory submissions to assure adequacy, completeness, and accuracy
- Coordinates the preparation of CMC submissions through editing and approval of final documents including review for quality in a timely manner
- Leads compilation of background information and preparations for CMC meetings with health authorities
- Has a solid understanding of CMC regulatory requirements including FDA and ICH guidelines and relevant government regulations as they apply to post approval changes to marketed products as well as the registration, development and approval of investigational products
- Researches up-to-date knowledge of regulatory requirements and communicates changes in regulatory information to director and project teams in a timely manner
- Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues. Communicates significant changes or other relevant matters to director and project teams in a timely manner
- Leads local and/or global submission process to assist in the overall efficiency of the regulatory submission process
- Manages regulatory CMC activities within time and budget for approved project plans
Education, Experience, Skills, and Knowledge Required:
- College degree, preferably in Chemistry or other scientific discipline, plus training and experience in regulatory affairs CMC
- 5 years or greater experience in the pharmaceutical industry with a minimum of 3 years of experience in regulatory CMC
- Solid understanding of CMC regulatory requirements (FDA and ICH guidelines)
- Prior expereince primarily supporting large molecule/biologics and working knowledge of monoclonial antibodies
- Computer application skills: Advanced MS Office, Adobe Acrobat skills
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Good oral and writing skills, strong work ethic
Behavioral Competencies Required:
- Ability to build and maintain positive relationships with management, peers, subordinates, and external clients.
- Display strong analytical and problem‑solving skills
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
- May encounter prolonged periods of sitting.
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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000