What experience and education do you need?
You’ll need to have a BS/MS degree in Chemistry or other scientific discipline plus training in regulatory affairs with 10+ years of related experience and/or training in the pharmaceutical industry with a minimum of 5 years in CMC regulatory.
Additionally, we are seeking candidates with the following experience:
- Significant experience interacting with at least one major health agency (FDA, Health Canada or EMA); interactions with one or more major health agencies desired
- Experience in preparing/reviewing regulatory IND/CTA and CTD NDA paper and/or electronic submissions
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
- A comprehensive understanding of CMC regulatory requirements including FDA and ICH guidelines and relevant government regulations as they apply to the registration, development and approval of investigational products as well as post approval changes to marketed products
- A demonstrated ability to contribute regulatory CMC expertise and advice
- Demonstrated analytical and problem solving skills
- Detail orientation, organizational skills and the ability to prioritize multiple tasks
- A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.
- Excellent interpersonal, verbal and written communication skills
- Leadership qualities: ethics, integrity, creativity, collaboration, etc.
- Advanced computer application skills in MS Office and Adobe Acrobat.
What else do you need to know?
- You’ll be required to travel approximately 10% of the time
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
All interested applicants should apply at: Omeros.com, About Omeros, Careers. This will route you to our online applicant tracking system.
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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.