Regulatory Strategy Director

As a Regulatory Strategy Director, the work centres on leading the development and execution of global regulatory strategies for renal therapy programs across all phases of development. It would suit someone who can bring flex Designation: Hybrid-Eligible Or On-Site Eligible to the role.

Role overview

Support lifecycle management activities, including new indications, formulation changes, manufacturing updates. Contribute to continuous improvement of regulatory processes, standards, and ways of working.

Main responsibilities

Leading the development and execution of global regulatory strategies for renal therapy programs across all phases of development. Serve as the regulatory representative on cross-functional program teams, providing strategic input to development plans, evidence generation, and milestone planning. Driving regulatory strategy & execution for major submissions, including INDs/CTAs, NDAs, BLAs, MAAs, supplements, variations, and other post-approval filings.

What helps someone succeed

Flex Designation: Hybrid-Eligible Or On-Site Eligible.

Requirements

• In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week.
• Or select On-Site: work five days per week on-site with ad hoc flexibility.
• Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Job details

• Time Type: Full Time.
• Job Requisition ID: REQ-29466.
• The Regulatory Affairs Director will provide global regulatory leadership for programs within the Renal Therapy Team.
• This role is responsible for defining and driving regulatory strategy for the International region that is aligned with global strategies to support timely advancement of investiga.