Manager, Regulatory Affairs Strategy - Oncology

Coordinate the preparation, submission, management and maintenance of global regulatory submissions Assist in coordination and preparation for Agency meetings and associated briefing document preparation Leads and tracks queries and commitments with regulatory agencies Collaborates with subject matter experts to provide written responses to queries Provides periodic status updates regarding conditions/commitments Provides representation for study-level regulatory activities Participates in cross-functional departmental team projects and product development activities/meetings Requirements Minimum MD, PhD or PharmD degree 2+ years of regulatory experience Worked on filings Helped with developing regulatory related documents Engaged with external partners and authorities Good understanding of US FDA and international pharmaceutical guidance Regulations and drug development process High attention to detail Strong interpersonal skills both written and verbally Core Competencies Demonstrates expertise in global regulatory submissions and compliance, with a strong understanding of US FDA and international pharmaceutical guidance. Proven ability to collaborate with cross-functional teams and engage with regulatory agencies effectively. Highest-signal resume keywords Regulatory Submissions Management US FDA Guidance Knowledge Regulatory Document Development Interpersonal Communication Skills Regulatory Experience ATS Optimization Keywords Hard Skills Regulatory Submissions Regulatory Document Preparation Filings Drug Development Process Regulatory Compliance Soft Skills Attention to Detail Written Communication Verbal Communication Certifications & Qualifications MD PhD PharmD Industry Keywords Regulatory Agencies Cross-Functional Collaboration Agency Meetings External Partners Pharmaceutical Guidance #J-18808-Ljbffr