Senior Specialist, Regulatory Affairs

About the Job
A growing commercial-stage biotechnology company focused on advancing innovative therapies in oncology and immunology is seeking a Senior Specialist, Health Authorities to support global clinical regulatory strategy and submission activities for investigational and marketed products. This individual will play a key role in preparing regulatory documentation, supporting health authority submissions, and ensuring clinical trials are conducted in accordance with applicable regulatory requirements.

Key Responsibilities

• Act as the POC for all health authority related conversations
• Support the development and execution of global clinical regulatory strategies for assigned products and programs.
• Review clinical data, reports, and summaries to ensure compliance with protocols, statistical analysis plans, monitoring guidelines, and data management requirements.
• Prepare and support regulatory submissions in eCTD format, including INDs, NDAs, BLAs, and other health authority filings.
• Draft and review regulatory documents, including Investigator Brochures, Clinical Study Reports, Protocols, Annual Reports, DSURs, Pharmacy Manuals, and ClinicalTrials.gov submissions.
• Coordinate responses to health authority inquiries and information requests.

Qualifications

• 7+ years of relevant experience, or Master's degree with 5+ years interacting with health authorities
• Experience preparing and submitting clinical modules in eCTD format
• Experience supporting IND, NDA, and/or BLA submissions
• Knowledge of Health Authority guidance documents, clinical research, GCP, and regulatory requirements and able to organize responses to Health Authority information requests
• International regulatory submissions experience is a plus