Regulatory Affairs Specialist/Sr. Specialist
The Regulatory Specialist provides support by helping to develop and execute against regulatory plans for one or more products. You will provide support to the implementation of regulatory tasks ensuring compliance to applicable regulatory requirements and regulations (e.g., FDA, EMA, and ICH) as well as scientific and company policies and department procedures.
Good things are happening at Omeros!
Come join our Omeros Regulatory Affairs & Quality Systems 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?
- Supports preparation and maintenance of program annual reports, and may support CMC, nonclinical, pharmacovigilance and other routine regulatory programs and other routine regulatory filings
- Conducts internet searches on regulatory topics to support development programs and department and company compliance
- Provides technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
- Coordinates, prepares, or reviews regulatory submissions for domestic and/or international projects
- If supporting a marketed product, reviews product promotional materials and labeling for compliance with applicable regulations and policies
- Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, as well as clarification and follow-up of submissions under review
- Ensures compliance with applicable regulations and guidelines (e.g., FDA, EMA, ICH)
- Interacts with and may have some oversight of vendor/contract research organization activities
- Escorts government inspectors during inspections and provides post-inspection follow-up information as requested
- Interprets regulatory rules or rule changes and ensures they are incorporated into corporate policies and procedures as appropriate
- Assists in writing or updating standard operating procedures, work instructions, or policies
- Advises project teams on subjects such as premarket regulatory requirements, labeling requirements, or clinical study regulatory compliance issues
- Identifies relevant guidance documents, international standards, or consensus standard and provides interpretive assistance
- Participates in internal or external audits
- Reviews clinical protocols to ensure collection of data needed for regulatory submissions.
- Coordinates recall or market withdrawal activities as necessary
- Manages regulatory tasks within time and budget of approved project plans
Education, Skills and Knowledge:
- Bachelor’s degree in a related field; advanced degree desirable; RAC certification desirable
- A minimum of 2 – 5 years of relevant experience for a Specialist or 5 – 7 years of relevant experience for a Sr. Specialist in Regulatory Affairs with drug or therapeutics biologic products is required
- Working knowledge of drug development guidelines and FDA regulations
- Familiarity with EMA or other OUS regulatory systems
- Strong organizational and planning skills to maintain a high level of productivity, innovation, and prioritization under tight timelines
- Excellent oral and written communication skills, including the ability to assist with the preparation of responses to health authority requests
- Strong proficiency with Microsoft Office suite including Word, Excel, and Power Point as well as Adobe Acrobat
- Attention to detail required
- Creativity and problem-solving skills
- Must represent Omeros in a professional manner
Behavioral Competencies Required:
- Demonstrated ability to identify issues and take appropriate actions
- The ability to build and maintain professional relationships with management, peers, and subordinates
Physical Demands Required:
- May frequently be performing repetitive movements such as typing on a keypad or using a mouse
- May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
- On occasion, may lift and/or move up to 25 pounds
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 Specialist $75,000 to $100,000 per year, or Sr Specialist $90,000 to $120,000 per year. Salaries will be determined based on knowledge, skills, education and experience relevant to the role. Employees are offered medical, dental, vision and life insurance and a 401k 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 bonus and stock options. To learn more about Omeros, please visit www.omeros.com.
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