Senior Regulatory Affairs Manager

JR United Kingdom; Slough; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

A forward-thinking company is on the lookout for a Senior Regulatory Affairs Manager to join their dynamic team in Slough. This exciting role involves providing strategic regulatory and scientific support for innovative medicines, ensuring compliance with European regulations. You will play a critical role in the development and registration processes, collaborating with diverse stakeholders and utilizing cutting-edge regulatory tools. If you have a passion for regulatory affairs and a desire to make a significant impact in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• Deep understanding of European regulatory requirements for specialty products.
• Experience with regulatory tools and software essential for submission processes.

Responsibilities

• Provide strategic regulatory support for clinical development plans.
• Collaborate with stakeholders to finalize Marketing Authorization Applications.

Skills

Regulatory Affairs

Project Management

Problem-Solving

Intercultural Communication

Teamwork

Education

Degree in Pharmacy

Degree in Life Sciences

Tools

eCTD

CESP

MHRA Portal

Eudralink

Microsoft Office

Job description

Senior Regulatory Affairs Manager, Slough

This role is with Pro4orm People Ltd, based in Slough, United Kingdom, and requires an EU work permit. The position is full-time and permanent, based in Berkshire three days a week.

Job Overview

We are seeking an experienced Senior Regulatory Affairs Manager with a strong understanding of European Regulatory requirements to support a global pharmaceutical company's development and registration processes within the EU.

Key Responsibilities

• Provide strategic regulatory and scientific support for non-clinical and clinical development plans to facilitate rapid access to innovative medicines.
• Contribute regulatory input into development programs and registration documentation, ensuring compliance with relevant guidelines.
• Identify and analyze applicable guidelines for product development and registration in Europe.
• Assess data critically, identify gaps, and prepare submission documentation.
• Participate in due diligence of dossiers, assessing modules 1 to 5, and respond to review questions.
• Collaborate with internal and external stakeholders to finalize Marketing Authorization Applications (MAA).

Requirements

• Deep understanding of European regulatory requirements, especially for specialty products in highly regulated territories.
• Skills in influencing, problem-solving, project management, adaptability, teamwork, and intercultural communication.
• Degree or higher in pharmacy, life sciences, or equivalent.
• Experience with Regulatory Affairs tools and software such as eCTD, CESP, MHRA portal, Eudralink, and Microsoft Office.

Application reference: 690852. Pro4orm People Ltd is an Equal Opportunities Employer. We will contact successful applicants within 5 working days. By applying, you agree to our Terms and Conditions and Privacy Policy.

Commitment to Diversity: We welcome applications from all qualified candidates regardless of race, gender, sexual orientation, religion, disability, or background.