Director, Regulatory Operations and Publishing

Director, Regulatory Operations and Publishing

Responsible for leading Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg., FDA, EMA, ICH, etc.).  Strong expertise in Regulatory Operations, Stakeholder Management with emphasis on teamwork and collaboration across multiple functions.
 

Good things are happening at Omeros!

Come join our Omeros Regulatory Team!

Who is Omeros? 

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?

• Leads staff who electronically format, publish electronic documents and builds Regulatory submission deliverables
• Ensures the highest quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures
• Manages submission activities related to pre-IND or Scientific Advice submissions, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, BLA annual reports and Investigator Brochures (IBs)
• Maintains industry standard expertise and leadership in the areas of FDA Study Standards in eCTD and CDISC-SEND data
• Provides guidance on good documentation and submission practices
• Assists with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, mentorship, and specifications
• Identifies regulatory system improvement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions
• Collaborates with third-party consultants and partners to develop, build and manage Content Planning documents for eCTD submission
• Assists with regulatory inspection activities
• Collaborates with vendors who support Regulatory operations related tasks
• Communicates the need for additional resources to management, as needed
• Functions as a contributor, as needed
• Provides support and backup to management, as needed

Education, Experience, Knowledge Required:

• Bachelor's Degree required
• 10-14 years of experience
• Requires solid understanding of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc.)
• Understands Key Regional Module 1 Regulatory Deliverables for US and ex-US Regions
• Strong knowledge of Regulatory Systems and eCTD knowledge
• Working knowledge of electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools, and XML are required
• Project management skills desired
• Solid understanding and a working knowledge of MS Office applications and Adobe Acrobat is required; proven understanding of MS Project and electronic document management systems (eg, SharePoint) are desirable
• Expertise in Lorenz DocuBridge and other submission software

Behavioral Competencies Required: 

• Ability to work and negotiate with stakeholders and provide best solutions to enable optimal submission hand-off strategies
• Good ability to pull people to a common goal
• Strategic Agility, be able to pivot and adopt submission strategies under tight timelines
• Attention to detail with a quality mind-set

Behavioral Competencies Required: 

• Ability to work and negotiate with stakeholders and provide best solutions to enable optimal submission hand-off strategies
• Good ability to pull people to a common goal
• Strategic Agility, be able to pivot and adopt submission strategies under tight timelines
• Attention to detail with a quality mind-set

Physical Demands Required:

• 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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000