Regulatory Affairs Analyst - PMTA & FDA Modernization (Remote)

Calculated Hire; Virginia (MN); Remote; USD 55,000 - 96,000; Full time

Benefits offered by this job

Flexible remote work environment

Opportunity to drive modernization initiatives

Collaborative and cross-functional team culture

Competitive hourly compensation

Job summary

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.

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.

Responsibilities

• 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.

Skills

Regulatory Affairs Experience

FDA Regulatory Frameworks

eCTD/Dossier Preparation

Analytical Skills

Communication Skills

Stakeholder Engagement

Tools

Veeva RIM

Job description

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.