Strategic Regulatory Lead – US & Canada

Clinical Dynamix, Inc.; Bridgewater Township (NJ); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Clinical Dynamix, Inc. seeks a Regulatory Affairs Manager to lead regulatory strategy and submissions for US and Canada. You will interface with health authorities and manage lifecycle activities to ensure compliance.

The ideal candidate has 5+ years in regulatory affairs, experience in a commercial-stage company, and strong project management in a fast-paced setting, with PV/regulatory collaboration as a plus.

Qualifications

• Bachelor’s degree required; life sciences advanced degree preferred.
• At least 5 years of regulatory affairs experience.
• Experience in a commercial-stage organization.
• Ability to deliver quality results in a fast-paced environment.

Responsabilités

• Develop and implement regulatory strategies for US and Canada.
• Prepare regulatory submissions and lifecycle management.
• Coordinate with FDA and Health Canada for drug development.
• Review documentation for IND submissions and lifecycle changes.
• Oversee submissions of advertising material to FDA as required.
• Maintain product labeling in compliance with regulations.
• Track PSURs and annual reports; ensure timely submissions.
• Collaborate with Medical Affairs & Pharmacovigilance on safety reporting.
• Ensure compliance with post-marketing reporting obligations.

Connaissances

Regulatory strategy

Regulatory submissions

Project management

FDA regulations

Pharmacovigilance

Formation

Bachelor's degree

Advanced life sciences degree

Outils

Veeva platform

Description du poste

Clinical Dynamix, Inc. seeks a Regulatory Affairs Manager to lead regulatory strategy and submissions for US and Canada. You will interface with health authorities and manage lifecycle activities to ensure compliance.

The ideal candidate has 5+ years in regulatory affairs, experience in a commercial-stage company, and strong project management in a fast-paced setting, with PV/regulatory collaboration as a plus.