Manager, Regulatory Affairs, CMC
Sr. Specialist/Manager, Regulatory Affairs CMC
Omeros is seeking a Sr. Specialist/Manager, Regulatory Affairs CMC. In this position you will be primarily responsible for the 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.
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
Come join our Regulatory Affairs CMC Team!
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
- 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
What education and experience do you need?
- BA/BS Degree in Chemistry or other scientific discipline, MS preferred, plus training in regulatory affairs
- For the Sr. Specialist level you will need 5+ years of experience in the pharmaceutical industry with a minimum of 2 years of experience in CMC regulatory, including working on biologics; for the Manager level, you will need 5 – 8 years of experience in a related discipline with a minimum of 3 years in CMC including working on biologics
- A solid understanding of CMC regulatory requirements including FDA and ICH guidelines for large molecule/biologics products as they apply to post-approval changes to marketed products as well as the registration, development, and approval of investigational products
- Prior expereince supporting large molecule/biologics
- Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
- Demonstrated ability to work with a cross functional team as well as independently
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Strong interpersonal and communication skills, both verbal and written
- Strong analytical and problem-solving skills
- Strong work ethic
- Computer application skills: Advanced MS Office, Adobe Acrobat skills
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.