Senior Regulatory Affairs Lead – Health Authorities

EPM Scientific; New Jersey; Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory strategy

Health authority liaison

Regulatory writing

GCP/regulatory knowledge

Ausbildung

Master's degree in life sciences

Jobbeschreibung

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.