Regulatory Affairs Sr. Specialist, CMC
As the Regulatory Affairs Sr. Specialist, CMC, you’ll play a vital role in 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/procedures.
Good things are happening at Omeros!
Come join our Regulatory Affairs Group!
Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.
What are your job responsibilities?
- Creating/compiling content of CMC documentation to regulatory agencies (NDA/MAA), setting the standards for CMC regulatory submissions to assure adequacy, completeness and accuracy
- Coordinating the preparation of CMC submissions through editing and approval of final documents including review for quality
- Leading compilation of background information and preparations for CMC meetings with health authorities
- Having 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
- Researching up-to-date knowledge of regulatory requirements and communicates changes in regulatory information to Director and project teams
- Maintaining current awareness of evolving health authority interpretations, including advisory letters, enforcement letters and policy issues as well as communicating significant changes or other relevant matters to Director and project teams
- Leading local and/or global submission process to assist in the overall efficiency of the regulatory submission process
- Managing regulatory CMC activities within time and budget for approved project plans
What experience, education and knowledge do you need?
You’ll need to have a minimum of a BS degree, preferably in Chemistry or other scientific disciple plus training and experience in regulatory affairs CMC. Additionally, we are seeking candidates with the following experience and knowledge:
- 5+ years of experience in the pharmaceutical industry with a minimum of 3 years of experience in regulatory CMC
- A solid understanding of the CMC regulatory requirements (FDA and ICH guidelines)
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
- High detail orientation, excellent organizational and planning skills and the ability to prioritize multiple tasks
- Strong computer application skills used in general office settings including word processing, spreadsheet, presentation software, and internet search engines
- Demonstrated analytical and problem-solving skills
- Demonstrated ability to identify issues and take appropriate action
- A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.
- Excellent interpersonal, verbal and written communication skills
- Ability to represent Omeros in a professional manner
- Relocation assistance will be offered
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
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.