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Specialist/Sr. Specialist, Regulatory Affairs CMC

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Sep 14, 2022

View more

Discipline
Clinical, Clinical Medicine, Science/R&D, CMC
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioForest
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Job Details

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  hr@omeros.com  or contact Omeros, asking for Human Resources, at (206) 676-5000.

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Find Us
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
98119
US
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