Regulatory Affairs Analyst

Technical Recruiter @ Calculated Hire | Ethical Advertising, Communication

Regulatory Affairs Analyst

Remote

1-YR Contract (possibility of extension)

Virginia, USA

Overview:

Our client is seeking a Regulatory Affairs Specialist to assess and enhance regulatory affairs processes, focusing on the preparation and submission of PMTA and SE applications in compliance with FDA requirements. In this role, you will conduct current state assessments, develop detailed process flow documentation, identify gaps or inefficiencies, and recommend modernization initiatives. You will collaborate closely with cross-functional teams to ensure alignment with regulatory standards and modernization goals. The ideal candidate will have strong experience with FDA regulatory frameworks, hands‑on expertise in eCTD/dossier preparation, and familiarity with regulatory information management systems such as Veeva RIM. Excellent analytical, communication, and stakeholder engagement skills are essential for success in this position.

Responsibilities:

• Conduct current state assessments of regulatory affairs processes and workflows with key stakeholders.
• Develop detailed process flow documentation and identify gaps or inefficiencies.
• Analyze opportunity areas and provide recommendations for modernization initiatives.
• Support preparation and submission of PMTA and SE applications in compliance with FDA requirements.
• Collaborate with cross-functional teams to ensure alignment with regulatory standards and modernization goals.

Qualifications:

• Proven experience in regulatory affairs, including PMTA and SE application processes.
• Strong knowledge of FDA regulatory frameworks and compliance requirements.
• Hands‑on experience with eCTD/dossier preparation and submission.
• Familiarity with Veeva RIM or similar regulatory information management systems.
• Excellent analytical, communication, and stakeholder engagement skills.
• Flexible remote work environment
• Opportunity to drive modernization initiatives in regulatory affairs
• Collaborative and cross‑functional team culture
• Competitive hourly compensation

Seniority Level

• Associate

Employment Type

• Full-time

Job Function

• Legal and Research

Industries

• Legal Services and Tobacco Manufacturing