Manager/Sr. Manager, Regulatory Affairs
Reporting to the Chief Regulatory Officer or designee, you’ll be responsible for managing and implementing the regulatory development plan for assigned programs ensuring they are in compliance with regulatory requirements.
Good things are happening at Omeros!
Come join our Omeros Regulatory Affairs & Quality Systems Team!
About Omeros Corporation
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.
What are your job responsibilities?
- Advising on the context and applicability of functional regulatory requirements for each assigned program appropriate to the stage of product development
- Coordinating the drafting, editing and preparation of regulatory submissions
- Ensuring the content and accuracy of regulatory fillings
- Overseeing and ensuring that the regulatory files and systems are maintained in accordance with department procedures, compliance standards, laws, and regulations
- Interacting with domestic and foreign regulatory agencies on assigned projects
- Working closely with clinical operations to ensure timely and accurate regulatory submissions related to clinical activities
- Serving as the regulatory representative at project meetings and interacting with cross-functional partners in order to achieve common goals
- Managing regulatory tasks within time and budget for approved project plans
- Communicating project status and issues
- Supervising the activities of regulatory associates and assistants
Education, Experience, Skills, and Knowledge Required:
You’ll need to have a BS/MS degree in a life science or a related field with a minimum of 5 – 7 years of regulatory affairs experience working in a biopharma company.Additionally, we are seeking candidates with the following experience and knowledge:
- Demonstrated knowledge of regulatory guidelines and regulations
- Drug development process knowledge
- Demonstrated ability to lead and manage projects
- Strong analytical and problem-solving skills
- Excellent organizational skills with a high level of accuracy and detail orientation
- Advanced computer application skills in MS Office and Adobe Acrobat
Behavioral Competencies Required:
- Demonstrated ability to handle multiple competing priorities, prioritize multiple tasks, and utilizing resources effectively
- A demonstrated ability to build and maintain positive relationships both internally and externally
- Excellent interpersonal, verbal and written communication skills
- Leadership qualities: ethics, integrity, creativity, collaboration, etc.
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
- May encounter prolonged periods of sitting
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.