Sr. Director of Regulatory Affairs
We are a growing and dynamic organization seeking a Sr. Director, Regulatory Affairs to join our Regulatory Affairs team. In this position, you will be responsible for leading the Regulatory Affairs function. This includes Regulatory CMC, Regulatory Managers, Regulatory Operations, Technical Writing, and Pharmacovigilance. In addition to oversight and management of the Regulatory Affairs function, you will be responsible for developing and implementing the regulatory plan for key programs.
Good things are happening at Omeros!
Come join our Regulatory Affairs Team!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
Your responsibilities in this position will include:
- Supervising the activities of the Regulatory Affairs team, which includes Regulatory CMC, Operations, Technical/medical writing, Pharmacovigilance, and support
- Advising on the context and applicability of global and national regulatory requirements for each program appropriate to the stage of product development
- Providing strategic direction and oversight in the preparation of regulatory submissions
- Ensuring content and accuracy of regulatory filings
- Preparing cross-functional teams for regulatory interactions
- Developing a regulatory strategy for development programs in conjunction with the cross-functional team
- Ensuring compliance with promotional and labeling regulatory requirements
- Interacting with domestic and foreign regulatory agencies on assigned projects
- Serving as the regulatory representative at project meetings and interacting with cross-functional team to achieve common goals
- Negotiating, interacting with, and supervising the regulatory activities of contract research organizations in the preparation of regulatory submissions
- Developing and overseeing the budget for regulatory affairs
- Communicating project status and issues to senior management
What education and experience do you need?
- You’ll need to have a university degree and a minimum of 8 years of related regulatory experience
- Experience in oversight and management of multifaceted department
- Direct experience in interacting with regulatory authorities and preparing cross-functional teams for such interactions
- Strong written and verbal communication skills with the demonstrated ability to communicate effectively and professionally
What knowledge and skills does our ideal candidate have?
- Knowledge of the drug development process and global regulatory guidelines
- Computer application skills: Advanced MS Office, Adobe Acrobat skills
- Highly detail oriented, well organized with the ability to prioritize multiple tasks to meet deadlines
- Excellent interpersonal and management skills with the ability to maintain positive relationships with management, peers, subordinates, and external organizations
- Effective and clear communicator, verbally and in writing
- Display strong analytical and problem-solving skills
- Strong work ethic
- Demonstrated leadership skills
- Ability to adapt to change
Other things you need to know:
- Some projects (e.g. major submissions) may require work days longer than 8 hours
- Occasionally, work with Europe may require being available outside of core working hours
If you have the experience, skills and knowledge that we are seeking, we’d love to hear from you. This is an exciting opportunity for the right person!