Regulatory Affairs Manager

Pharma Partners Recruitment Ltd; Reading; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Berkshire is looking for a Regulatory Affairs Manager. The role involves implementing regulatory strategies for a portfolio of products in Europe, ensuring compliance with guidelines, and maintaining liaison with the EMA. The ideal candidate will have experience in Regulatory Affairs, particularly within the pharmaceutical industry, and will possess excellent organizational skills.

Benefits

Car Allowance

Annual Bonus

Private Healthcare

Qualifications

• Experience in Regulatory Affairs within the pharmaceutical industry.
• European regulatory experience is essential.

Responsibilities

• Implement regulatory strategies and deliverables for drug development.
• Ensure compliance with Europe Region guidelines.

Skills

Organizational Skills

Motivation

Cross-Cultural Communication

Job description

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Job title: Regulatory Affairs Manager

A Top 10 Pharmaceutical company in Berkshire is seeking a Regulatory Affairs Manager to join their team. In this role, you will implement regulatory strategies and deliverables for a portfolio of early/late development and marketed products in Europe.

Responsibilities:

• Implement regulatory strategies and deliverables, including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products in the assigned Therapeutic Area.
• Ensure compliance of drug development activities with Europe Region guidelines, providing critical analysis of risks and issues when deviations occur.
• Support drug development strategies by defining options for Scientific Advice/Pediatric Investigation Plans, creating briefing packages, and coordinating agency meetings.
• Maintain direct liaison with EMA for products within the Therapeutic area.

Requirements:

• Pharmaceutical industry experience in Regulatory Affairs.
• European regulatory experience is essential.
• Experience with Neuroscience products is beneficial.
• Ability to work effectively across cultures and in complex matrixed environments.
• Excellent organizational skills and high motivation.

Salary and benefits:

A highly competitive salary, car allowance, annual bonus, private healthcare, and wider benefits are on offer.

To apply or hear further details, please click “Apply” or contact via email: [e-mail].