About the job
AL Solutions are partnered with a global Regulatory Consulting firm who are searching for a Senior/Principal level Consultant to support on an upcoming Oncology project.
The ideal candidate will have deep expertise in oncology, strong regulatory writing experience, and the ability to lead document development independently while collaborating with cross-functional teams.
Key Responsibilities:
Lead the development of high-quality regulatory documents including:
- Clinical Study Protocols, Investigator Brochures (IBs), Informed Consent Forms (ICFs),
- Clinical Study Reports (CSRs), Briefing Books, IND Modules, BLA/NDA components.
- Breakthrough Therapy Designation Requests, Fast Track Applications.
- Collaborate with internal and client teams including regulatory strategists, clinical leads, statisticians, and medical monitors.
- Manage timelines, content development, and review cycles with minimal supervision.
- Provide strategic input on document content and regulatory messaging.
- Ensure documents comply with applicable regulatory guidelines (ICH, FDA, EMA).
- Mentor junior writers and review their work as needed.
- Participate in client meetings and regulatory interactions when required.
This will be a part time role (roughly 15-20 hours per week) and will run for 6 – 12 months.
