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Head of Regulatory Affairs and Compliance
Scientific Supplier
Regulatory & Compliance
Real World Data
Europe & US
£80,000 - £100,000
Pharma/Biotech
Role Overview
You will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance.
Company Information
Zenopa have partnered with a multinational business that offers global pharma firms comprehensive solutions for launching precision medicine diagnostics. All of their employees work remotely or in a hybrid model, and their culture is unique in that it centres around having fun. They create an open environment for working together, being listened to and understood, even when working remotely. This builds a strong channel of communication and trust within their workforce.
Role Requirements
Develop and execute global regulatory strategies for clinical programs to ensure timely submissions and successful product registrations.
Lead the preparation and submission of key regulatory documents, including INDs, NDAs, BLAs, and briefing materials for Health Authority meetings.
Serve as the primary regulatory advisor, analyzing and communicating regulatory requirements and updates to internal teams and clients.
Oversee and mentor the Regulatory Affairs team, driving internal growth, resource planning, and global budget management.
Provide regulatory leadership in business development, contributing to sales targets and the expansion of regulatory consulting services.
Ensure compliance with international regulations, company SOPs, and industry best practices across all regulatory activities.
Person Specifications
Bachelor’s degree in related discipline.
10+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience.
Expert knowledge of all aspects of the drug development process inclusive of regulatory milestones.
Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development.
Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines.
Expertise in preparing complex regulatory documents and other major regulatory submissions.
Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills.
Availability for domestic and international travel including overnight stays.
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Locations
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
Date Updated
15 May 2025
Job reference
73198
Categories
Full Time
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The Zenopa Salary Guide is based on Zenopa industry experience, it is not specific to this particular job, but it is useful to provide you indicative information and enable you to find jobs when searching salary bands. Individual jobs salary ranges are frequently not released into the public domain, this will be released to you upon application.
Why Zenopa?
We aim to operate and maintain the following set of core values
