Regulatory Affairs - Contractor

Overview

On Site
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 21 day((s))

Skills

PMTA
regulatory affairs
Veeva RIM
Tobacco or Pharma industry experience

Job Details

Job Description, Day to Day, Education, Certification, etc.:

Notes:

Details of the request include:

Must-have skill requirements of the role: PMTA, regulatory affairs, Veeva RIM. Candidates should have experience in the tobacco industry; pharmaceutical experience is the second preference

Number of openings: 1

Location / Travel Onsite Requirements: Hybrid. They are expected to be at the client site in Virginia sometimes and working remotely other times. The first week will either be onsite at the client site in Richmond or at EY in McLean.

Contract Description:

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/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.

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