Associate Manager, Regulatory Affairs Strategy - Oncology
Core
Support the Global Regulatory Liaison in preparing, submitting, and managing global regulatory submissions for oncology therapeutics, ensuring compliance with regulations across quality, preclinical, and clinical development.
Role type
Associate Manager, Regulatory Affairs Strategy (Oncology)
Builds
Global regulatory submissions (INDs/CTAs, amendments, Orphan drug applications, Annual Reports, Investigator's Brochure) for oncology therapeutic products
Domain
Biopharmaceuticals / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of US FDA and international pharmaceutical regulations, drug development process, and industry standard practices, Experience interacting with CROs for ex-US/ex-EU CTA management, Ability to organize and prioritize projects, Proficient written and oral communication in English
Preferred skills
Experience in oncology therapeutic area, Advanced degree (Master's/PhD), Experience with clinical trial activations
Technologies
Regulatory submission systems, CRO management platforms
Responsibilities
Coordinate preparation and submission of global regulatory submissions for clinical and nonclinical aspects, Assist in coordination and preparation for Agency meetings and briefing documents, Manage and track queries and commitments with regulatory agencies, Provide representation for study-level regulatory activities, Perform research to support regulatory strategy development, Maintain knowledge of current regulatory requirements and guidance
Seniority
Associate Manager, hands-on IC