Global Regulatory Strategy Lead (Hybrid)

Vertex UK Int'l HQ/R&D; Boston (MA); Hybrid; GBP 120,000 - 170,000; Full time

Job summary

Vertex UK Int'l HQ/R&D is seeking a Regulatory Strategy Senior Manager to lead regional regulatory strategy for development programs and marketed products. The role covers regional/or global responsibilities within the Vertex portfolio, with emphasis on US, Europe, and international markets.

The candidate should understand regulatory affairs frameworks, drug development concepts, and have a track record in interactions with health authorities.

Qualifications

• In-depth knowledge of global and regional regulatory affairs frameworks.
• Good understanding of drug development concepts including clinical trial design and pharmacology.
• Experience with regulatory submissions, health authority interactions, and post-market surveillance.

Responsibilities

• Leads development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs team.
• Contributes to and may lead global regulatory strategy development for certain programs.
• Responsible for regulatory communications with local health authorities and may lead interactions.
• Guides teams on regulatory requirements for development and approval pathways for the region.
• Manages preparation, submission, and approval of regulatory applications within the region.
• Provides regulatory input for key product development or registration documents.
• Ensures submissions comply with current regulations and guidance.
• Reviews regulatory intelligence to inform strategy in the assigned region.

Skills

Regulatory affairs knowledge

Drug development understanding

Regulatory communications

Team collaboration

Problem solving

Written and verbal communication

Education

Bachelor's degree in Biology, Chemistry, or related discipline

Job description

Vertex UK Int'l HQ/R&D is seeking a Regulatory Strategy Senior Manager to lead regional regulatory strategy for development programs and marketed products. The role covers regional/or global responsibilities within the Vertex portfolio, with emphasis on US, Europe, and international markets.

The candidate should understand regulatory affairs frameworks, drug development concepts, and have a track record in interactions with health authorities.