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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in regulatory affairs with a focus on clinical-stage radiopharmaceutical programs, including extensive experience in preparing and coordinating regulatory submissions such as INDs and New Drug Applications. Strong leadership and collaboration skills to align cross-functional teams and ensure compliance with US FDA requirements.
Highest-signal resume keywords
Regulatory Affairs ExperienceUS FDA Requirements KnowledgeIND Submission CoordinationRegulatory Medical WritingLeadership in Oncology Programs
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory SubmissionsIND AmendmentsNew Drug ApplicationsElectronic Submission PublishingDocument ManagementSubmission StandardsHealth Authority InteractionsClinical Operations CoordinationData Gap ResolutionSubmission Calendars
Soft Skills
Clear CommunicationStrong Scientific JudgmentDetail-OrientedProactiveCollaborative Leadership
Industry Keywords
BiotechPharmaceuticalRadiopharmaceutical DevelopmentPatient SafetyQuality Compliance
About the role
Key responsibilities & impact- Serve as the point of contact for Health Authorities
- Translate program regulatory strategy into interaction plans, submission plans, timelines, and cross-functional deliverables for clinical-stage radiopharmaceutical programs
- Lead preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions
- Schedule and coordinate meeting rehearsals before Health Authority interactions
- Finalize meeting minutes with Health Authorities, responses to information requests, and follow-up actions
- Oversee publishing and submissions
- Partner with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative
- Maintain records of correspondence, commitments, decisions, and submission history
- Establish and maintain regulatory plans, workflows, submission calendars, trackers, and archives
- Coordinate regulatory medical writing across functions and translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables
Requirements
What you’ll need- Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred
- 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry
- Leadership in regulatory interaction deliverables supporting pre-IND to Phase 3 investigational-stage oncology programs
- Strong knowledge of US FDA requirements and interaction processes
- Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests
- Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors
- Experience leading submission of New Drug Applications and Marketing Authorization Applications is helpful
- Familiarity with radiopharmaceutical development is helpful
- Clear, concise communication with strong scientific judgment and exceptional writing and editing skills
- Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines
- Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders
- Collaborative leadership and ability to align subject matter experts, challenge constructively, and drive decisions
- Commitment to quality, compliance, and patient safety
Benefits
Comp & perks- A unique chance to contribute to first-in-class cancer therapies
- Exposure to both radiochemistry and CMC development in a dynamic biotech setting
- Hands-on training and professional development opportunities
- An international, collaborative, and supportive work culture
- Competitive compensation and benefits