Manager, Regulatory Affairs Strategy – Oncology

Jobtailor; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor in New Jersey is seeking an experienced regulatory professional to coordinate global submissions and support agency meetings. You will work with subject matter experts to prepare high-quality regulatory documents and respond to agency queries.

Candidates should have an MD/PhD/PharmD and 2+ years regulatory experience, with strong US FDA knowledge, attention to detail and excellent written and verbal communication.

Qualifications

• MD, PhD or PharmD required.
• 2+ years of regulatory experience.
• Experience with filings.
• Developed regulatory documents.
• Engaged with external partners and authorities.
• Strong knowledge of US FDA and international guidance.
• Understanding of drug development process.
• High attention to detail.
• Strong interpersonal skills, written and verbal.

Responsibilities

• Coordinate global regulatory submissions preparation and management.
• Assist in Agency meeting coordination and briefing documents.
• Lead and track queries and commitments with regulatory agencies.
• Collaborate with SMEs to provide written responses to queries.
• Provide periodic status updates on conditions/commitments.
• Represent for study-level regulatory activities.
• Participate in cross-functional team projects and product development meetings.

Skills

Regulatory Submissions Management

US FDA Guidance Knowledge

Regulatory Document Development

Interpersonal Communication Skills

Regulatory Experience

Education

MD

PhD

PharmD

Job description

• 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