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Regulatory Affairs Operations Specialist

2 months ago

Bethesda, Maryland, United States Technical Resources International Full time

Position Title: Regulatory Operations Associate

Location: Bethesda, MD

Category: Regulatory Affairs

Job Type: Full-Time

Education: Bachelor's Degree

Travel: None

Job Overview:

The Regulatory Operations Associate is responsible for preparing standard documentation that supports regulatory submissions and ensures effective distribution to relevant stakeholders.

Key Responsibilities:

  • Utilize and maintain both hard copy and electronic filing systems for regulatory documents, ensuring they are auditable.
  • Foster effective communication and interactions with colleagues, collaborators, and clients as necessary.
  • Draft, edit, and disseminate various documents as required, following established templates and work instructions.
  • Develop and sustain work process tools aimed at enhancing efficiency and productivity, including templates, SOPs, work instructions, and checklists.
  • Monitor regulatory activities, maintain and update databases, ensuring records are complete and current.
  • Provide additional administrative support in regulatory matters as needed.

Qualifications:

Excellent oral and written communication skills are essential, along with a detail-oriented approach and the ability to manage multiple tasks effectively.

Superior organizational skills and strong customer service capabilities are required.

Preferred qualifications include experience in publishing regulatory submissions using electronic submission software and proficiency in preparing documents that meet electronic submission standards.

Proficiency in MS Office (Word, Excel, and Outlook) is necessary; experience with SharePoint is advantageous.

The candidate must demonstrate initiative, sound judgment, and the ability to prioritize ongoing projects.

Familiarity with Good Clinical Practices and/or experience in an FDA-regulated environment is desirable.

A general understanding of the drug and vaccine development process or clinical trials is a plus.

Diversity Commitment:

We are equal opportunity/affirmative action employers, dedicated to fostering 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.