Regulatory Affairs Manager

Verbatim Pharma; United Kingdom; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Verbatim Pharma is seeking a Regulatory Affairs Manager to join their Global Clinical Trial Services team in a hybrid UK role. You will develop regulatory intelligence, craft regulatory plans, and provide project-based support, leveraging a solid grasp of EU directives, US CFR, and GMP/GDP regulations.

You will operate within a close-knit regulatory team, contributing to continuous improvement and ensuring compliance across global trials in a pivotal, patient-focused environment.

Qualifications

• Solid grasp of EU directives, US CFR, and GMP/GDP regulations.
• Develop regulatory intelligence materials and regulatory plans.
• Provide project-based regulatory support within a small team.

Responsibilities

• Develop regulatory intelligence materials and regulatory plans.
• Provide project-based regulatory support to trial teams.
• Collaborate within a small regulatory team to ensure compliance.

Skills

EU directives

US CFR

GMP/GDP

Regulatory intelligence

Regulatory planning

Job description

Regulatory Affairs Manager (EAP/Managed Access) - Global Clinical Trial Services - Hybrid Opportunity

Are you ready to advance your career and join a business who are a leader in Clinical Services? Providing the opportunity to specialise in a niche area of a business who have 3 key divisions, providing exposure to an area of the pharmaceutical industry being directly involved in saving the lives of some of the most vulnerable patients in the world.

As part of our close-knit regulatory team of three, you'll dive into developing intelligence materials, creating regulatory plans, and offering project-based support. You'll need a solid grasp of EU directives, US CFR, and GMP/GDP regulations.

Why this role?

• You can delve into a classic RA position, with a fantastic team of specialists
• Opportunities to progress, learn new things in a fast paced environment!
• This businesses passion trumps any other, truly matching your work ethic and in an extremely patient focussed space
• One of the biggest service provider of this specialist area
• Giving someone the freedom to shape key parts of the reg team and function

Alternate Job Titles:

RA Manager / RA Specialist / Regulatory Affairs Specialist / Reg Affairs Specialist / QA Manager / Quality Assurance