Regulatory Operations Associate

Location

Bethesda, MD 20817 US (Primary)

Category

Regulatory Affairs

Job Type

Full-Time

Salary Range

54,000.00-60,000.00/YEAR

Education

Bachelor's Degree

Travel

None

Job Description

• Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
• Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
• Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
• Draft, edit, and distribute various documents as needed based on templates and work instructions.
• Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
• Track regulatory activity, maintain, and update databases, and ensure that records are complete and current.
• Provide other administrative regulatory support as needed.

Job Requirements

• Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
• Superior organizational skills and customer service abilities are required.
• Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
• Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
• Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
• Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
• General knowledge of the drug and vaccine development process or clinical trials is a plus.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.