Senior Regulatory Affairs Leader — Clinical Strategy

Value Apothecaries; Conshohocken (Montgomery County); Sur place; CAD 120 000 - 180 000; Plein temps

Résumé du poste

Cencora is seeking a Senior Manager, Regulatory Affairs with a clinical focus to provide strategic, client-facing regulatory consulting across the health product lifecycle. You will lead complex regulatory projects and interact with Regulatory Authorities (Health Canada and FDA) and cross-functional colleagues.

This role emphasizes translating evolving regulatory requirements into actionable guidance, developing product labeling, supporting launches, and managing multiple projects to meet

Qualifications

• Bachelor's degree in life sciences or regulatory field.
• 5-8 years in regulatory affairs across lifecycle.
• Experience with Health Canada and FDA is a plus.
• Clinical research or regulatory consulting background preferred.

Responsabilités

• Lead regulatory strategy and consulting engagements for life sciences clients.
• Prepare and maintain regulatory submissions across CTAs, INDs, NDAs, and PLAs.
• Interface with Regulatory Authorities and clients.
• Collaborate with cross-functional teams to align regulatory with development and commercial goals.
• Manage multiple projects within scope, timelines, and budgets.

Connaissances

Regulatory strategy

Client leadership

Project management

Regulatory submissions

Cross-functional collaboration

Formation

Bachelor's degree in life sciences

Advanced degree preferred

Description du poste

Cencora is seeking a Senior Manager, Regulatory Affairs with a clinical focus to provide strategic, client-facing regulatory consulting across the health product lifecycle. You will lead complex regulatory projects and interact with Regulatory Authorities (Health Canada and FDA) and cross-functional colleagues.

This role emphasizes translating evolving regulatory requirements into actionable guidance, developing product labeling, supporting launches, and managing multiple projects to meet