Regulatory Affairs Specialist, Oncology Therapy Area
Orion
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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Salary
💰 $100,000 - $150,000 per year
About the role
- Support preparation, compilation, and maintenance of regulatory submissions (e.g., INDs, amendments, annual reports, briefing documents, CTAs).
- Assist with eCTD publishing coordination and document lifecycle management in collaboration with Regulatory Operations or external vendors.
- Perform quality control (QC) checks to ensure regulatory documents are complete, accurate, and submission-ready.
- Contribute to the execution of regulatory strategies as defined by Regional Regulatory Experts or Global Regulatory Leads.
- Assist with regulatory intelligence gathering (e.g., guidance review, precedent research) to support development decisions.
- Track regulatory commitments, milestones, and agency feedback.
- Work closely with Clinical Development, Clinical Operations, Medical Writing, CMC, and external partners to gather required inputs for submissions.
- Support coordination of internal review cycles and comment reconciliation.
- Assist in preparation of materials for health authority interactions (e.g., FDA, EMA).
- Support documentation of meeting outcomes and follow-up actions.
- Maintain regulatory trackers, timelines, and submission plans.
- Support inspection readiness activities and document archiving.
- Contribute to continuous improvement of regulatory processes, templates, and ways of working.
Requirements
- Bachelor’s degree in life sciences, pharmacy, public health, or a related field (advanced degree a plus).
- At least 2 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Basic understanding of U.S. and/or EU regulatory frameworks for clinical development.
- Experience supporting regulatory submissions or regulatory documentation.
- Strong attention to detail, organizational skills, and ability to manage multiple tasks in parallel.
- Clear written and verbal communication skills.
- Experience supporting oncology development programs (preferred but not required).
- Familiarity with INDs, CTAs, or global clinical trial applications.
- Exposure to eCTD structure and publishing workflows.
- Experience working with CROs or external regulatory vendors.
- Working knowledge of regulatory systems (e.g., document management systems, submission tracking tools).
Benefits
- Inclusive work environment
- Opportunities for professional growth and development
- A chance to be part of a mission-driven organization
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionseCTD publishingquality controlregulatory strategiesregulatory intelligenceregulatory documentationoncology development programsINDsCTAsregulatory frameworks
Soft Skills
attention to detailorganizational skillscommunication skillsability to manage multiple tasks