DirectorSr. Director, Regulatory Affairs CMC
DirectorSr. Director, Regulatory Affairs CMC
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Job Description
Director/Sr Director Regulatory Affairs CMC
Good things are happening at Omeros!
Come join our Regulatory Affairs Team!
This position is responsible for the CMC strategic regulatory direction interactions with international regulatory agencies regulatory CMC submissions and operational CMC regulatory expertise to advance the companys drug candidates in accordance with current regulations and department procedures.
Who is Omeros
Omeros is an innovative biopharmaceutical company committed to discovering developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases and cancers as well as addictive and compulsive disorders. Omeros lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA and EMA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. OMS906 Omeros inhibitor of MASP-3 the key activator of the alternative pathway of complement is in clinical development for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by theNational Institute on Drug Abuse Omeros lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs visit.
Skills and Experience Required:
- Develops /advises on the regulatory CMC strategy appropriate to the stage of product development
- Implements strategy to advance projects through development to product registration
- 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/IMPD; NDA/BLA/MAA) setting the standards for CMC regulatory submissions to assure quality completeness and regulatory accuracy.
- Coordinates with CMC QA and upper management for 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
- Serves as a bridge across the CMC Regulatory Affairs and QA functions
- Leads the companys interactions with domestic and foreign regulatory agencies on CMC issues.
- Serves as the regulatory representative at project meetings
- Interacts with contract manufacturing organizations in the preparation of regulatory submissions as necessary.
- Manages regulatory CMC activities within time and budget for approved project plans.
Experienceand Education Required:
- BS MS or PhD in chemistry or other scientific discipline plus training in regulatory affairs
- Minimum of 7 years in regulatory CMC
- Experience interacting with major health agencies (e.g. FDA Health Canada EMA)
What Were Looking for in an Ideal Candidate:
- 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.
- Must have the ability to build and maintain positive relationships with management peers and subordinates.
- Strong work ethic
- Excellent cross-functional leadership skills
Other Requirements:
- The employee will be required to have overnight travel (10-15%).
Physical Demands:
- May encounter prolonged periods of sitting
Compensation and Benefits:
Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for this position is(Director - $195000-$240000; Sr Director $230000 - $280000).Salaries will be determined based on knowledge skills education and experience relevant to the role. Employees are offered medical dental vision life insurance and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for incentive and stock options. To learn more about Omeros please .
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 or contact Omeros asking for Human Resources at .
Required Experience:
Exec
Employment Type
Full-Time
