Specialist/Sr. Specialist, Regulatory Affairs CMC
We are seeking a Specialist/Sr. Specialist who will be 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 and be a part of our Regulatory Affairs & QA 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 .
Essential Duties & Responsibilities:
- Prepares content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy
- Reviews and edits final documents for regulatory CMC submissions in a timely manner
- Prepares information and related activities for CMC meetings with health authorities
- Possesses 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
- Stays 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
- Maintains current awareness of evolving regulatory environment including advisory letters, enforcement letters and policy issues
- Participates as needed, in 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
- Helps define and implement strategic regulatory CMC activities across programs
Education, Experience, Skills, and Knowledge Required:
- MS degree in Chemistry or other scientific discipline is preferred, plus training in regulatory affairs
- 2 – 5 or 5 plus years of experience, dependent on level, 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, subordinates, and external partners
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting, up to 20 lbs.
- May encounter prolonged periods of sitting
If you have the experience, skills and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!
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.