Regulatory Affairs Analyst

Calculated Hire; Virginia (MN); Remote; USD 55.000 - 96.000; Vollzeit

Benefits dieser Stelle

Flexible remote work environment

Opportunity to drive modernization initiatives

Collaborative and cross-functional team culture

Competitive hourly compensation

Zusammenfassung

A leading recruiting firm is seeking a Regulatory Affairs Analyst for a remote position. The ideal candidate will assess and enhance regulatory processes, focusing on PMTA and SE application submissions per FDA requirements. Responsibilities include conducting assessments, developing documentation, and collaborating with teams to align with regulations. Candidates should have experience in FDA frameworks, eCTD preparation, and possess strong analytical and communication skills. This role offers competitive hourly compensation and a collaborative team culture.

Qualifikationen

• 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

Aufgaben

• Conduct current state assessments of regulatory affairs processes with stakeholders.
• Develop detailed process flow documentation and identify inefficiencies.
• Analyze opportunity areas and provide recommendations for modernization.
• 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.

Kenntnisse

Regulatory Affairs Experience

FDA Regulatory Frameworks

eCTD/Dossier Preparation

Analytical Skills

Communication Skills

Stakeholder Engagement

Analytical skills

Tools

Veeva RIM

Jobbeschreibung

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