Sr. Manager/Associate Director, Regulatory Affairs
The Sr. Manager/Associate Director, Regulatory Affairs is responsible for regulatory leadership and strategy for multiple development programs and for contributing to the lifecycle development of clinical and commercial program across various disease areas.
Good things are happening at Omeros!
Come join our Omeros Regulatory & Quality Assurance 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 and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
- Advising on the context and applicability of global and national regulatory requirements for development programs appropriate to the stage of product development
- Providing leadership and mentoring to department staff with emphasis on development and integration of regulatory plans and strategies for products in early development through post- commercialization
- Serving as the regulatory representative at project meetings and interacting with cross- functional team to achieve common goals
- Being the lead author on key regulatory submissions (e.g., briefing documents, applications for expedited programs)
- Developing a regulatory strategy for assigned development programs in conjunction with the cross-functional team
- Interacting with domestic and foreign regulatory agencies on assigned projects
- Preparing cross-functional teams for regulatory interactions
- Providing strategic direction for regulatory submissions
- Ensuring content and accuracy of regulatory submissions for assigned development programs
- Negotiating, interacting with, and supervising the regulatory activities of contract research organizations in the preparation of regulatory submissions for assigned development programs
- Communicating project status and issues to senior management
- Other relevant duties as assigned
Education, Experience, Skills, and Knowledge Required:
- A BS degree and a minimum of 7 years of related experience in the pharmaceutical industry for a Sr. Manager level and a minimum 10 years of experience in the pharmaceutical industry for an Associate Director level
- Experience in oversight and management of development programs
- 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
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Excellent teamwork and collaboration capabilities
- Knowledge of the drug development process and global regulatory guidelines
- Computer application skills: Advanced MS Office, Adobe Acrobat skills
- Excellent interpersonal and management skills with the ability to maintain positive relationships with management, peers, subordinates, and external organizations
- Display strong analytical and problem-solving skills
Behavioral Competencies Required:
- Strong work ethic
- Demonstrated leadership skills
- Ability to adapt to change
- Ability to represent Omeros in a professional manner
- Some periods (e.g., major submissions) may require workdays longer than 8 hours
- Occasionally, work with international vendors may require being available outside of core working hours
- Occasional overnight and/or international travel
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or liftinto 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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000
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Job posted: 2021-07-28