Sr. Director. Regulatory Affairs, CMC
Sr. Director, Regulatory Affairs CMC
This position is responsible for the CMC strategic regulatory direction, interactions with U.S. and international regulatory agencies, regulatory CMC submissions, and operational CMC regulatory expertise to advance the company’s drug candidates in accordance with current regulations and department procedures.
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?
- Develops /advises on the regulatory CMC strategy appropriate to the stage of product development
- Implements strategy to advance projects through development to product registration
- Has 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
- Drives content of CMC documentation to regulatory agencies (IND/CTA; NDA/BLA/MAA), setting the standards for CMC regulatory submissions to assure quality, completeness, and regulatory accuracy
- Coordinates the preparation of CMC submissions through drafting, editing, and approval of final draft documents including review for quality
- Coordinates preparation of information and related activities for CMC meetings with regulatory authorities
- Advises upper management regarding strategic regulatory CMC topics
- Interacts directly with domestic and foreign regulatory agencies on CMC issues
- Serves as the regulatory representative at project meetings and interacts with personnel from corporate partners in order to achieve common goals
- Negotiates, interacts with, and supervises the activities of contract manufacturing organizations in the preparation of regulatory submissions, as necessary
- Manages regulatory CMC activities within time and budget for approved project plans
Education, Experience, Skills, and Knowledge Required:
- A BS/MS in chemistry or other scientific discipline plus training in regulatory affairs CMC
- Prior expereince primarily supporting large molecule/biologics and working knowledge of monoclonial antibodies
- 12 years or more in the pharmaceutical industry with a minimum of 8 years in CMC regulatory
- Significant experience interacting with at least one major health agency (e.g., FDA, Health Canada or EMA)
- Ability to provide regulatory CMC expertise and advice to upper management
- Experienced in preparing / reviewing / approving regulatory CMC submissions
- Computer application skills: Advanced MS Office, Adobe Acrobat skills
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Good verbal and written communication skills
- Must display strong analytical and problem-solving skills
Behavioral Competencies Required:
- Must have the ability to build and maintain positive relationships with management, peers, and subordinates
- Strong work ethic
- Excellent cross-functional leadership skills
- You’ll be required to travel 10% - 15% of the time
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, or pulling
- 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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000