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

• 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

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.

• Regulatory Submissions Management
• US FDA Guidance Knowledge
• Regulatory Document Development
• Interpersonal Communication Skills
• Regulatory Experience

• Regulatory Submissions
• Regulatory Document Preparation
• Filings
• Drug Development Process
• Regulatory Compliance

• Attention to Detail
• Written Communication
• Verbal Communication

• MD
• PhD
• PharmD

• Regulatory Agencies
• Cross-Functional Collaboration
• Agency Meetings
• External Partners
• Pharmaceutical Guidance