Regulatory Operations Associate

About the role

Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate. Provide administrative regulatory support as needed.

Responsibilities

• Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
• Draft, edit, and distribute various documents based on templates and work instructions.
• Develop and maintain work process tools to promote efficiency and productivity, including templates, SOPs, work instructions, and checklists.
• Track regulatory activity, maintain, and update databases, ensuring records are complete and current.

Requirements

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