Senior Specialist, Regulatory Affairs

EPM Scientific; New Jersey; Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

EPM Scientific is seeking a Senior Specialist, Health Authorities in the United States to support global clinical regulatory strategy and submission activities for investigational and marketed products. You will help prepare regulatory documentation and ensure trials comply with applicable requirements.

Responsibilities include acting as the main contact for health authorities, supporting IND/NDA/BLA submissions, and drafting key regulatory documents while coordinating inquiries efficiently.

Qualifications

• 7+ years of relevant regulatory experience or a Master's with 5+ years coordinating with health authorities.
• Experience preparing and submitting clinical modules in eCTD format.
• Knowledge of regulatory guidance, clinical research, and GCP.
• Experience with IND, NDA, or BLA submissions is preferred.

Responsabilités

• Act as the point of contact for health authority conversations.
• Support global regulatory strategies for assigned products and programs.
• Review data and documents to ensure compliance with protocols and data management requirements.
• Prepare and support regulatory submissions in eCTD format (INDs, NDAs, BLAs).
• Draft and review regulatory documents such as CSRs, Investigator Brochures, and annual reports.
• Coordinate responses to health authority inquiries and information requests.

Connaissances

Regulatory strategy

Health authority liaison

Regulatory writing

GCP/regulatory knowledge

Formation

Master's degree in life sciences

Description du poste

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