Senior Specialist Regulatory Affairs
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
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